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

• 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: Apyx Medical
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Sub-Dermal Neck Renuvion APR Device - Study Phase I	Sub-Dermal Neck Renuvion APR Device - Study Phase II	Total
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
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)

Outcome Measures

1. Primary Outcome

Title	Day 180 Number of Participants With Improvement Measured By Independent Photographic Review
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

Outcome Measure Data

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
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%

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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%

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)
Description	Subject Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time Frame	90-Day

Outcome Measure Data

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
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)
Description	Subject Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time Frame	180-Day

Outcome Measure Data

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
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)
Description	Investigator Modified GAIS:Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time Frame	90-Day

Outcome Measure Data

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
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)
Description	Investigator Modified GAIS: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time Frame	180-Day

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

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
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%)
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.
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 and Caveats

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.

More Information

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

• Name/Title: Kari Larson, MBA, Sr. Director, Clinical Affairs
• Organization: Apyx Medical
• Phone: 8012440058
• EMail: kari.larson@apyxmedical.com

• 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