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Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04146467
Recruitment Status : Completed
First Posted : October 31, 2019
Results First Posted : July 8, 2022
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Apyx Medical

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lax Skin
Intervention Device: Renuvion APR Device
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Period Title: Overall Study
Started 17 65
Completed 17 62
Not Completed 0 3
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             0             2
Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II Total
Hide Arm/Group Description

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Total of all reporting groups
Overall Number of Baseline Participants 17 65 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Average Age Number Analyzed 17 participants 65 participants 82 participants
58.5  (4.0) 55.9  (6.3) 56.4  (5.9)
Age, Customized  
Median (Inter-Quartile Range)
Unit of measure:  Years
Median Age Number Analyzed 17 participants 65 participants 82 participants
59
(56 to 62)
57.0
(51 to 61)
57.0
(53 to 61.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 65 participants 82 participants
Female
16
  94.1%
59
  90.8%
75
  91.5%
Male
1
   5.9%
6
   9.2%
7
   8.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 65 participants 82 participants
Asian
1
   5.9%
1
   1.5%
2
   2.4%
Hispanic or Latino
1
   5.9%
3
   4.6%
4
   4.9%
White
14
  82.4%
61
  93.8%
75
  91.5%
Other: Greek Spanish
1
   5.9%
0
   0.0%
1
   1.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 65 participants 82 participants
17 65 82
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 17 participants 65 participants 82 participants
36.49  (4.1) 25.4  (4.9) 25.5  (4.7)
Body Mass Index (BMI)  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 17 participants 65 participants 82 participants
25.5
(22.6 to 28.3)
24.7
(22.8 to 27.0)
24.8
(22.7 to 27.6)
1.Primary Outcome
Title Day 180 Number of Participants With Improvement Measured By Independent Photographic Review
Hide Description Improvement in the appearance of lax tissue in the neck and submental region at 6 months as determined by qualitative 2D photography assessment by blinded Independent Photographic Reviewers. Three experienced, blinded photographic reviewers performed a qualitative analysis/review of the pre-treatment and post-treatment sets of images of each subject in a blinded and randomized order. Each blinded reviewer chose which image was the post-treatment image. Success was correct post-treatment image selection by at least 2 of the 3 reviewers. The percentage of subjects with a correct post-treatment image selection was calculated.
Time Frame 180-Day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description:

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Overall Number of Participants Analyzed 7 63
Measure Type: Count of Participants
Unit of Measure: Participants
6
  85.7%
52
  82.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sub-Dermal Neck Renuvion APR Device - Study Phase II
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Subject Reported Pain - None to Moderate
Hide Description

The primary safety endpoint is the level of pain and discomfort after treatment as reported by the subject on an 11-point Numeric Rating Scale (NRS) through the 7-day follow-up visit where 0 is no pain and 10 is the most pain. Pain scores are classified as scores of 0 being no pain, 1 - 5 is minor pain, 6 - 7 is moderate pain, and 8 - 10 is severe pain.

The primary safety objective is to demonstrate that the proportion of subjects with none-to- moderate pain exceeds the performance goal (PG). The performance goal is 55%.

Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description

Phase I: 17 total participants started Phase I. 4 participants missed their Day 7 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, Day 7 data for Subject Reported Pain was only analyzed for 13 participants.

Phase II: 65 participants started Phase 2. 1 participant exited the study prior to Day 7 follow-up visit. Therefore, Day 7 data for Subject Reported Pain was only analyzed for 64 participants.

Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description:

All subjects treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Subjects treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Overall Number of Participants Analyzed 13 64
Measure Type: Count of Participants
Unit of Measure: Participants
13
 100.0%
62
  96.9%
3.Other Pre-specified Outcome
Title Day 90 Number of Participants With Improvement Measured By Independent Photographic Review
Hide Description Change in the appearance of lax tissue in the neck and submental region at 90-days as determined by qualitative 2D photography assessment by blinded Independent Photographic Reviewers. Three experienced, blinded photographic reviewers performed a qualitative analysis/review of the pre-treatment and post-treatment sets of images of each subject in a blinded and randomized order. Each blinded reviewer chose which image was the post-treatment image. Success was correct post-treatment image selection by at least 2 of the 3 reviewers. The percentage of subjects with a correct post-treatment image selection was calculated.
Time Frame 90-Day
Hide Outcome Measure Data
Hide Analysis Population Description

Phase I: 17 total participants started Phase I. 7 participants missed their D90 images due to COVID-19 office closures and/or restrictions. Therefore, D90 Independent Photographic Review data was only available for 10 participants.

Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D90 visit and 1 participant was lost to follow-up prior to D90 Follow-up visit. Therefore, Day 90 Independent Photographic Review data was only available for 63 participants.

Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description:

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Overall Number of Participants Analyzed 10 63
Measure Type: Count of Participants
Unit of Measure: Participants
8
  80.0%
48
  76.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sub-Dermal Neck Renuvion APR Device - Study Phase II
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0004
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Subject Modified Global Aesthetic Improvement Scale (GAIS)
Hide Description Subject Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time Frame 90-Day
Hide Outcome Measure Data
Hide Analysis Population Description

Phase I: 17 total participants started Phase I. 1 participant missed their D90 Modified GAIS due to COVID-19 office closures and/or restrictions. Therefore, D90 Subject Modified GAIS data was only available for 16 participants.

Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D90 visit and 1 participant was lost to follow-up prior to D90 Follow-up visit. Therefore, Day 90 Subject Modified GAIS data was only available for 63 participants.

Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description:

All subjects treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Overall Number of Participants Analyzed 16 63
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Improved
0
   0.0%
7
  11.1%
Much Improved
7
  43.8%
18
  28.6%
Improved
5
  31.3%
33
  52.4%
No Change
3
  18.8%
3
   4.8%
Worse
0
   0.0%
1
   1.6%
Much Worse
0
   0.0%
1
   1.6%
Very Much Worse
1
   6.3%
0
   0.0%
5.Other Pre-specified Outcome
Title Subject Modified Global Aesthetic Improvement Scale (GAIS)
Hide Description Subject Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time Frame 180-Day
Hide Outcome Measure Data
Hide Analysis Population Description
Phase-II discrepancy is due to 1 subject exited due to an AE during treatment and 2 subject lost to follow-up prior to Day 180 visit. Which brought the numbers to: Phase-II 62
Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description:

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Overall Number of Participants Analyzed 17 62
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Improved
4
  23.5%
12
  19.4%
Much Improved
5
  29.4%
17
  27.4%
Improved
3
  17.6%
24
  38.7%
No Change
3
  17.6%
7
  11.3%
Worse
1
   5.9%
2
   3.2%
Much Worse
0
   0.0%
0
   0.0%
Very Much Worse
1
   5.9%
0
   0.0%
6.Other Pre-specified Outcome
Title Investigator Modified Global Aesthetics Improvement Scale (GAIS)
Hide Description Investigator Modified GAIS:Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time Frame 90-Day
Hide Outcome Measure Data
Hide Analysis Population Description

Phase I: 17 total participants started Phase I. 2 participants completed virtual visits and 1 participant missed their D90 visit due to COVID-19 office closures and/or restrictions. Therefore, D90 Investigator GAIS data was only available for 14 participants.

Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D90 visit and 1 participant was lost to follow-up prior to D90 visit. Therefore, Day 90 Investigator GAIS data was only available for 63 participants.

Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description:

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Overall Number of Participants Analyzed 14 63
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Improved
0
   0.0%
8
  12.7%
Much Improved
3
  21.4%
19
  30.2%
Improved
8
  57.1%
33
  52.4%
No Change
2
  14.3%
3
   4.8%
Worse
1
   7.1%
0
   0.0%
Much Worse
0
   0.0%
0
   0.0%
Very Much Worse
0
   0.0%
0
   0.0%
7.Other Pre-specified Outcome
Title Investigator Modified Global Aesthetic Improvement Scale (GAIS)
Hide Description Investigator Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time Frame 180-Day
Hide Outcome Measure Data
Hide Analysis Population Description
Phase-II discrepancy is due to 1 subject exited due to an AE during treatment and 2 subject lost to follow-up prior to Day 180 visit. Which brought the numbers to: Phase-II 62
Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description:

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Overall Number of Participants Analyzed 17 62
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Improved
2
  11.8%
8
  12.9%
Much Improved
6
  35.3%
19
  30.6%
Improved
5
  29.4%
27
  43.5%
No Change
3
  17.6%
6
   9.7%
Worse
1
   5.9%
2
   3.2%
Much Worse
0
   0.0%
0
   0.0%
Very Much Worse
0
   0.0%
0
   0.0%
8.Other Pre-specified Outcome
Title Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure
Hide Description At 180 days post procedure, the subject's satisfaction with the procedure was assessed using a Patient Satisfaction Questionnaire. Questions were YES or NO questions pertaining to satisfaction with study treatment, observations of improvement, and considerations for recommendation.
Time Frame 180-Day
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D180 visit and 2 participants was lost to follow-up prior to D180 Follow-up visit. Therefore, Day 180 Patient Satisfaction Questionnaire data was only available for 62 participants.
Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description:

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Overall Number of Participants Analyzed 17 62
Measure Type: Count of Participants
Unit of Measure: Participants
Number of Subjects that Answered YES to Happy With Results of Procedure
12
  70.6%
47
  75.8%
Number of Subjects that Answered YES to More Jawline Definition NA [1] 
39
  62.9%
Number of Subjects that Answered YES to Reduction in Jowls NA [1] 
20
  32.3%
Number of Subjects that Answered YES to Improvement in Skin Texture in Treatment Area NA [1] 
20
  32.3%
Number of Subjects that Answered YES to Reduction in the Area Under the Chin NA [1] 
41
  66.1%
Number of Subjects that Answered YES to Reduction of Lines & Wrinkles in the Treatment Area NA [1] 
21
  33.9%
Number of Subjects that Answered YES to Other Changes NA [1] 
10
  16.1%
Number of Subjects that Answered YES to Would Recommend Procedure to a Friend
12
  70.6%
46
  74.2%
Number of Subjects that Answered YES to Would Consider Having the Procedure on Another Body Area
11
  64.7%
47
  75.8%
[1]
Data not collected in Study Phase I
9.Other Pre-specified Outcome
Title Quantitative Improvement in Overall Lift of the Neck and Submental Area
Hide Description Quantitative improvement in overall lift of the neck and submental area as determine by quantitative assessment based on 2D photography with Canfield Vectra system analysis. Fixed landmarks on the subject's face were used.
Time Frame 180-Day
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D180 visit, 1 participant completed a virtual visit, and 2 participants were lost to follow-up prior to D180 Follow-up visit. Therefore, Day 180 Quantitative Improvement data was only available for 61 participants.
Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description:

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Overall Number of Participants Analyzed 0 61
Measure Type: Count of Participants
Unit of Measure: Participants
38
  62.3%
10.Other Pre-specified Outcome
Title Quantitative Improvement in Submental Volume
Hide Description Quantitative improvement in submental volume at 180 days as determined by quantitative assessment based on 3D photography with Canfield Vectra system analysis.
Time Frame 180-Day
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D180 visit, 2 participants were lost to follow-up prior to D180 visit, 1 participant completed a virtual visit for D180 and did not have photographs for volume assessment, and 1 subject had poor image quality that resulted in the inability to assess volume change. Therefore, Day 180 Quantitative Improvement in Submental Volume was only available for 60 participants.
Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description:

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Overall Number of Participants Analyzed 0 60
Measure Type: Count of Participants
Unit of Measure: Participants
41
  68.3%
11.Other Pre-specified Outcome
Title Average Pain at Day 7 Reported by Subject
Hide Description Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Time Frame 7-Day
Hide Outcome Measure Data
Hide Analysis Population Description

Phase I: 17 total participants started Phase I. 4 participants missed their D7 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, D7 Average Pain data was only available for 13 participants.

Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D7 visit . Therefore, Day 7 Average Pain data was only available for 64 participants.

Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description:

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Overall Number of Participants Analyzed 13 64
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.23  (1.24) 0.6  (1.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sub-Dermal Neck Renuvion APR Device - Study Phase II
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
12.Other Pre-specified Outcome
Title Median Pain Reported by Subject at Day 7
Hide Description Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Time Frame 7-Day
Hide Outcome Measure Data
Hide Analysis Population Description

Phase I: 17 total participants started Phase I. 4 participants missed their D7 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, D7 Median Pain data was only available for 13 participants.

Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D7 visit . Therefore, Day 7 Median Pain data was only available for 64 participants.

Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description:

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Overall Number of Participants Analyzed 13 64
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
1.0
(0 to 3)
0.0
(0 to 1)
13.Other Pre-specified Outcome
Title Average Pain Reported by Subject at Day 30
Hide Description Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Time Frame 30-Day
Hide Outcome Measure Data
Hide Analysis Population Description

Phase I: 17 total participants started Phase I. 2 participants missed their D30 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, D30 Average Pain data was only available for 15 participants.

Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D30 visit and1 participant was lost to follow-up prior to D30 visit. Therefore, Day 30 Average Pain data was only available for 63 participants.

Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description:

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Overall Number of Participants Analyzed 15 63
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.33  (2.66) 0.2  (0.5)
14.Other Pre-specified Outcome
Title Median Pain Reported by Subject at Day 30
Hide Description Level of pain and discomfort after treatment as reported by the subject on a 11-point Numeric Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Time Frame 30-Day
Hide Outcome Measure Data
Hide Analysis Population Description

Phase I: 17 total participants started Phase I. 2 participants missed their D30 follow-up visit due to COVID-19 office closures and/or restrictions. Therefore, D30 Median Pain data was only available for 15 participants.

Phase II: 65 total participants started Phase 2. 1 participant exited the study prior to D30 visit and1 participant was lost to follow-up prior to D30 visit. Therefore, Day 30 Median Pain data was only available for 63 participants.

Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase I Sub-Dermal Neck Renuvion APR Device - Study Phase II
Hide Arm/Group Description:

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Overall Number of Participants Analyzed 15 63
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
0
(0 to 9)
0.0
(0 to 0)
Time Frame Through 6 month follow-up visit for all enrolled subjects
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sub-Dermal Neck Renuvion APR Device - Study Phase II Sub-Dermal Neck Renuvion APR Device - Study Phase I
Hide Arm/Group Description

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All subjects will be treated with the Renuvion APR device.

Renuvion APR Device: The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

All-Cause Mortality
Sub-Dermal Neck Renuvion APR Device - Study Phase II Sub-Dermal Neck Renuvion APR Device - Study Phase I
Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)      0/17 (0.00%)    
Hide Serious Adverse Events
Sub-Dermal Neck Renuvion APR Device - Study Phase II Sub-Dermal Neck Renuvion APR Device - Study Phase I
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/65 (4.62%)      0/17 (0.00%)    
Gastrointestinal disorders     
Lower GI Bleed * [1]  1/65 (1.54%)  1 0/17 (0.00%)  0
General disorders     
Acute Appendicitis * [1]  1/65 (1.54%)  1 0/17 (0.00%)  0
Renal and urinary disorders     
Kidney Stone * [1]  1/65 (1.54%)  1 0/17 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Not related to device or procedure.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sub-Dermal Neck Renuvion APR Device - Study Phase II Sub-Dermal Neck Renuvion APR Device - Study Phase I
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   62/65 (95.38%)      16/17 (94.12%)    
Nervous system disorders     
Temporary motor nerve Injury (nerve weakness, muscle atrophy, twitching, and paralysis) *  4/65 (6.15%)  1/17 (5.88%) 
Skin and subcutaneous tissue disorders     
Edema/Swelling * [1]  60/65 (92.31%)  14/17 (82.35%) 
Temporary sensory nerve injury (loss of sensation) * [1]  57/65 (87.69%)  5/17 (29.41%) 
Ecchymosis/ bruising * [1]  36/65 (55.38%)  10/17 (58.82%) 
Erythema * [1]  32/65 (49.23%)  3/17 (17.65%) 
Crepitus * [1]  27/65 (41.54%)  3/17 (17.65%) 
Pain/tenderness * [1]  16/65 (24.62%)  5/17 (29.41%) 
Nodules/subcutaneous lumps (migratory firmness) * [1]  8/65 (12.31%)  6/17 (35.29%) 
Pruritus/itching (not related to nerve injury) *  4/65 (6.15%)  0/17 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
Expected Treatment Effect
Limitations of this study was the pandemic that occurred in the middle of the study and caused study visits to be more challenging for all subjects enrolled.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kari Larson, MBA, Sr. Director, Clinical Affairs
Organization: Apyx Medical
Phone: 8012440058
EMail: kari.larson@apyxmedical.com
Layout table for additonal information
Responsible Party: Apyx Medical
ClinicalTrials.gov Identifier: NCT04146467    
Other Study ID Numbers: VP-1902
First Submitted: October 29, 2019
First Posted: October 31, 2019
Results First Submitted: April 29, 2022
Results First Posted: July 8, 2022
Last Update Posted: July 20, 2022