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The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST) (FROST)

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: NCT02922153
Recruitment Status : Completed
First Posted : October 4, 2016
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Device: Cryoanalgesia
Drug: Standard of Care
Enrollment 84
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cryoanalgesia + Standard of Care (SOC) Standard of Care
Hide Arm/Group Description

Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.

Cryoanalgesia: AtriCure® cryoICE cryo-ablation system

Standard of Care: Institutional SOC for pain management will be followed.

Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.

Standard of Care: Institutional SOC for pain management will be followed.

Period Title: Overall Study
Started 65 19
Completed 55 17
Not Completed 10 2
Reason Not Completed
Death             8             1
Lost to Follow-up             1             0
Physician Decision             1             1
Arm/Group Title Cryoanalgesia + Standard of Care (SOC) Standard of Care Total
Hide Arm/Group Description

Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.

Cryoanalgesia: AtriCure® cryoICE cryo-ablation system

Standard of Care: Institutional SOC for pain management will be followed.

Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.

Standard of Care: Institutional SOC for pain management will be followed.

Total of all reporting groups
Overall Number of Baseline Participants 65 19 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 19 participants 84 participants
63.83  (11.96) 66.42  (12.53) 64.42  (12.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 19 participants 84 participants
Female
27
  41.5%
8
  42.1%
35
  41.7%
Male
38
  58.5%
11
  57.9%
49
  58.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 19 participants 84 participants
American Indian or Alaska Native
0
   0.0%
1
   5.3%
1
   1.2%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.5%
0
   0.0%
1
   1.2%
White
59
  90.8%
18
  94.7%
77
  91.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
   7.7%
0
   0.0%
5
   6.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 65 participants 19 participants 84 participants
65 19 84
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 65 participants 19 participants 84 participants
28.61  (5.03) 29.95  (4.73) 28.91  (4.96)
Forced Expiratory Value (FEV1)  
Mean (Standard Deviation)
Unit of measure:  Liters (L)
Number Analyzed 65 participants 19 participants 84 participants
2.33  (0.78) 2.28  (0.84) 2.32  (0.79)
Visual Analog Scale (general)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 65 participants 19 participants 84 participants
0.32  (0.95) 0.42  (0.90) 0.35  (0.94)
[1]
Measure Description: 0-10 Numeric Pain Rating Scale
Visual Analog Scale (surgical site)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 65 participants 19 participants 84 participants
0.03  (0.25) 0.21  (0.54) 0.07  (0.34)
[1]
Measure Description: 0-10 Numeric Pain Rating Scale at the surgical site.
Society of Thoracic Surgeon Score (STS)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 60 participants 19 participants 79 participants
2.03  (1.90) 2.86  (2.57) 2.23  (2.09)
[1]
Measure Description: Risk of Mortality Percentage - High is greater than or equal to 8%, intermediate is greater than or equal to 4% and low is less than 4%.
[2]
Measure Analysis Population Description: The information required in this data field was not obtained on five of the sixty-five participants. Data was reported on sixty participants.
1.Primary Outcome
Title Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery
Hide Description Forced Expiratory Volume (FEV1) is the measurement of how much air, in volume, that a person can exhale with a forced breath. It is measured using a spirometer device.
Time Frame 48-hours post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients who were consented and randomized (84). Not all subjects in each of the arms participated. Some refused to participate or were unable to participate in data collection which resulted in fewer subjects able to be analyze. This resulted in 46/64 subject for Cryoanalgesia (CRYO) + SOC and 16/19 subjects for SOC.
Arm/Group Title Cryoanalgesia + SOC Standard of Care
Hide Arm/Group Description:

Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.

Cryoanalgesia: AtriCure® cryoICE cryo-ablation system

Standard of Care: Institutional SOC for pain management will be followed.

Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.

Standard of Care: Institutional SOC for pain management will be followed.

Overall Number of Participants Analyzed 46 16
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Liters (L)
1.2
(1.10 to 1.31)
0.93
(.71 to 1.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0223
Comments [Not Specified]
Method t-test, 1 sided
Comments One-sided, two-sample t-test.
2.Primary Outcome
Title Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery
Hide Description The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically.
Time Frame 48-hours post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes all patients who were consented and randomized (84). However, not all subjects in each of the arms participated. Some refused to participate or were unable to participate in data collection which resulted in fewer subjects able to be analyze. This resulted in 61/64 subject for CRYO + SOC and 18/19 subjects for SOC.
Arm/Group Title Cryoanalgesia + SOC Standard of Care
Hide Arm/Group Description:

Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.

Cryoanalgesia: AtriCure® cryoICE cryo-ablation system

Standard of Care: Institutional SOC for pain management will be followed.

Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.

Standard of Care: Institutional SOC for pain management will be followed.

Overall Number of Participants Analyzed 61 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.82  (2.70) 3.06  (2.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6259
Comments [Not Specified]
Method t-test, 1 sided
Comments One-sided two-sample t-test.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.518
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon two-sample test.
3.Secondary Outcome
Title Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation
Hide Description Spirometry assessments measured included: forced expiratory volume (FEV1), forced vital capacity (FVC) and slow vital capacity (SVC), all of which are measured with a spirometer. FEV1 is the amount of air forcibly expired during the first second of breath, FVC is the total volume of air expired over the whole forced breath and SVC is the total volume over the whole breath but at a slow pace, not forced.
Time Frame 48-hours post-extubation
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes all patients who were consented and randomized (84). However, not all subjects in each of the arms participated. Some refused to participate or were unable to participate in data collection which resulted in fewer subjects able to be analyze. This resulted in 46/64 subject for CRYO + SOC and 16/19 subjects for SOC.
Arm/Group Title Cryoanalgesia + SOC Standard of Care
Hide Arm/Group Description:

Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.

Cryoanalgesia: AtriCure® cryoICE cryo-ablation system

Standard of Care: Institutional SOC for pain management will be followed.

Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.

Standard of Care: Institutional SOC for pain management will be followed.

Overall Number of Participants Analyzed 46 16
Mean (Standard Deviation)
Unit of Measure: Liters (L)
FEV1 1.20  (0.46) 0.93  (0.43)
FVC 1.60  (0.62) 1.33  (0.55)
SVC 1.52  (0.61) 1.28  (0.55)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0201
Comments FEV1 one-sided, two-sample t-test
Method t-test, 1 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments FVC one-sided, two-sample t-test
Method t-test, 1 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments SVC one-sided, two-sample t-test
Method t-test, 1 sided
Comments [Not Specified]
4.Secondary Outcome
Title Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points
Hide Description The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically.
Time Frame 72-, 96- and 120-hours Post-Op
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants decreases at each subsequent visit due to patients being discharged at different time points during hospital stay.
Arm/Group Title Cryoanalgesia + SOC Standard of Care
Hide Arm/Group Description:

Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.

Cryoanalgesia: AtriCure® cryoICE cryo-ablation system

Standard of Care: Institutional SOC for pain management will be followed.

Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.

Standard of Care: Institutional SOC for pain management will be followed.

Overall Number of Participants Analyzed 64 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
72 Hours Post-Op Number Analyzed 59 participants 18 participants
2.08  (2.39) 1.44  (2.09)
96 Hours Post-Op Number Analyzed 51 participants 15 participants
1.84  (2.39) 2.00  (2.45)
120 Hours Post-Op Number Analyzed 42 participants 10 participants
2.50  (2.82) 2.40  (3.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3085
Comments 72 Hours Post-Op
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank-sum test
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8196
Comments 96 Hours Post-Op
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank-sum test.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7269
Comments 120 Hours Post-Op
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank-sum test.
5.Secondary Outcome
Title Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit
Hide Description Allodynia is pain around surgical site. It is pain that occurs from stimuli that are not normally painful such as a light touch or a brush of hair around where the surgery took place.
Time Frame 3 and 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cryoanalgesia + SOC Standard of Care
Hide Arm/Group Description:

Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.

Cryoanalgesia: AtriCure® cryoICE cryo-ablation system

Standard of Care: Institutional SOC for pain management will be followed.

Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.

Standard of Care: Institutional SOC for pain management will be followed.

Overall Number of Participants Analyzed 64 19
Measure Type: Count of Participants
Unit of Measure: Participants
3 Month
0
   0.0%
0
   0.0%
6 Month
1
   1.6%
0
   0.0%
6.Secondary Outcome
Title Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room
Hide Description Oral endotracheal intubation is where a patient has a tube placed down their throat and into the trachea, the large airway from the mouth to the lungs. This is done to ensure that patients who are asleep under anesthesia are able to fully breath. This outcome measured the hours from the time the patient leaves the operating room until they were extubated, or had the tube removed from their trachea.
Time Frame Hours until patient is extubated from time patient leaves the operating room
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number is for all patients that were fully extubated and accounts for patients who were unable to be extubated or did were unable to finish extubation.
Arm/Group Title Cryoanalgesia + SOC Standard of Care
Hide Arm/Group Description:

Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.

Cryoanalgesia: AtriCure® cryoICE cryo-ablation system

Standard of Care: Institutional SOC for pain management will be followed.

Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.

Standard of Care: Institutional SOC for pain management will be followed.

Overall Number of Participants Analyzed 60 19
Mean (Standard Deviation)
Unit of Measure: Hours
8.85  (11.16) 7.33  (4.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments Analysis is the time from end of procedure to oral endotracheal extubation
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4421
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank-sum test
7.Secondary Outcome
Title Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points
Hide Description Patient Controlled Analgesia (PCA) is when the patient chooses to give themselves some form of analgesia, or painkiller, depending on their post-operation pain levels. Oral opioid consumption is the measure of all painkiller medicine that was prescribed by the hospital to the patient to take. This outcome measures each of these up to each time point and also measures the total PCA and oral opioid consumption post-procedure for the whole hospital stay.
Time Frame 24-, 48, -96 and 120-hours
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants decreases at each subsequent visit due to patients being discharged at different time points during hospital stay.
Arm/Group Title Cryoanalgesia + SOC Standard of Care
Hide Arm/Group Description:

Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.

Cryoanalgesia: AtriCure® cryoICE cryo-ablation system

Standard of Care: Institutional SOC for pain management will be followed.

Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.

Standard of Care: Institutional SOC for pain management will be followed.

Overall Number of Participants Analyzed 63 19
Mean (Standard Deviation)
Unit of Measure: Morphine Milligram Equivalent (MME)
24 Hours Number Analyzed 63 participants 19 participants
11.43  (14.54) 17.32  (23.65)
48 Hours Number Analyzed 63 participants 19 participants
20.91  (23.45) 31.05  (36.02)
96 Hours Number Analyzed 57 participants 15 participants
14.87  (19.82) 16.67  (44.52)
120 Hours Number Analyzed 47 participants 12 participants
14.10  (18.58) 13.13  (20.40)
Total Post-Procedure for Hospital Stay Number Analyzed 63 participants 19 participants
33.43  (29.77) 38.31  (31.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4352
Comments Total Post-Procedure for Hospital Stay
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon Rank-Sum Test
8.Secondary Outcome
Title Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge
Hide Description The outcome measures the time spent in the intensive care unit (ICU) as well as the total hospital length of stay.
Time Frame Procedure to Discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cryoanalgesia + SOC Standard of Care
Hide Arm/Group Description:

Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.

Cryoanalgesia: AtriCure® cryoICE cryo-ablation system

Standard of Care: Institutional SOC for pain management will be followed.

Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.

Standard of Care: Institutional SOC for pain management will be followed.

Overall Number of Participants Analyzed 60 19
Mean (Standard Deviation)
Unit of Measure: Days
ICU Length of Stay 4.96  (7.75) 2.96  (2.24)
Hospital Length of Stay 9.40  (8.34) 6.32  (2.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2939
Comments ICU Length of Stay
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank-sum test
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0998
Comments Hospital Length of Stay
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon rank-sum test
9.Secondary Outcome
Title Secondary Outcome 7: Ambulatory Movement During Hospital Stay
Hide Description Ambulatory Movement, defined as the subjects ability to sit up, stand up, walk and flex both the left and right shoulders, was measured at multiple time points during hospital stay.
Time Frame Baseline, 48, 72, 96, 120 Hours and Discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Initial patient population was 65 and 19 for the CRYO arm and SOC arm respectively. Number of patients analysed at the time points below differs due to the following: patient unwilling or refused test, patient discharged from hospital or other patient hospital stay issues.
Arm/Group Title Cryoanalgesia + SOC Standard of Care
Hide Arm/Group Description:

Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.

Cryoanalgesia: AtriCure® cryoICE cryo-ablation system

Standard of Care: Institutional SOC for pain management will be followed.

Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.

Standard of Care: Institutional SOC for pain management will be followed.

Overall Number of Participants Analyzed 65 19
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline - Able to sit up in bed Number Analyzed 65 participants 19 participants
Yes - Independently
65
 100.0%
19
 100.0%
Yes - with assistance
0
   0.0%
0
   0.0%
No
0
   0.0%
0
   0.0%
Baseline - Able to stand up Number Analyzed 65 participants 19 participants
Yes - Independently
64
  98.5%
19
 100.0%
Yes - with assistance
1
   1.5%
0
   0.0%
No
0
   0.0%
0
   0.0%
Baseline - Able to walk Number Analyzed 65 participants 19 participants
Yes - Independently
64
  98.5%
19
 100.0%
Yes - with assistance
1
   1.5%
0
   0.0%
No
0
   0.0%
0
   0.0%
Baseline - Right shoulder flexion movement Number Analyzed 65 participants 19 participants
Yes - Independently
63
  96.9%
19
 100.0%
Yes - with assistance
2
   3.1%
0
   0.0%
No
0
   0.0%
0
   0.0%
Baseline - Left shoulder flexion movement Number Analyzed 65 participants 19 participants
Yes - Independently
64
  98.5%
19
 100.0%
Yes - with assistance
1
   1.5%
0
   0.0%
No
0
   0.0%
0
   0.0%
48 Hours - Able to sit up in bed Number Analyzed 61 participants 17 participants
Yes - Independently
34
  55.7%
7
  41.2%
Yes - with assistance
27
  44.3%
10
  58.8%
No
0
   0.0%
0
   0.0%
48 Hours - Able to stand up Number Analyzed 61 participants 17 participants
Yes - Independently
21
  34.4%
4
  23.5%
Yes - with assistance
38
  62.3%
12
  70.6%
No
2
   3.3%
1
   5.9%
48 Hours - Able to walk Number Analyzed 61 participants 17 participants
Yes - Independently
16
  26.2%
2
  11.8%
Yes - with assistance
38
  62.3%
13
  76.5%
No
7
  11.5%
2
  11.8%
48 Hours - Right shoulder flexion movement Number Analyzed 61 participants 16 participants
Yes - Independently
26
  42.6%
8
  50.0%
Yes - with assistance
33
  54.1%
8
  50.0%
No
2
   3.3%
0
   0.0%
48 Hours - Left shoulder flexion movement Number Analyzed 61 participants 16 participants
Yes - Independently
43
  70.5%
12
  75.0%
Yes - with assistance
16
  26.2%
4
  25.0%
No
2
   3.3%
0
   0.0%
72 Hours - Able to sit up in bed Number Analyzed 59 participants 17 participants
Yes - Independently
47
  79.7%
8
  47.1%
Yes - with assistance
12
  20.3%
9
  52.9%
No
0
   0.0%
0
   0.0%
72 Hours - Able to stand up Number Analyzed 59 participants 17 participants
Yes - Independently
39
  66.1%
5
  29.4%
Yes - with assistance
20
  33.9%
10
  58.8%
No
0
   0.0%
2
  11.8%
72 Hours - Able to walk Number Analyzed 59 participants 17 participants
Yes - Independently
28
  47.5%
4
  23.5%
Yes - with assistance
27
  45.8%
11
  64.7%
No
4
   6.8%
2
  11.8%
72 Hours - Right shoulder flexion movement Number Analyzed 59 participants 17 participants
Yes - Independently
41
  69.5%
12
  70.6%
Yes - with assistance
17
  28.8%
5
  29.4%
No
1
   1.7%
0
   0.0%
72 Hours - Left shoulder flexion movement Number Analyzed 59 participants 17 participants
Yes - Independently
49
  83.1%
15
  88.2%
Yes - with assistance
8
  13.6%
2
  11.8%
No
2
   3.4%
0
   0.0%
96 Hours - Able to sit up in bed Number Analyzed 51 participants 15 participants
Yes - Independently
41
  80.4%
12
  80.0%
Yes - with assistance
10
  19.6%
3
  20.0%
No
0
   0.0%
0
   0.0%
96 Hours - Able to stand up Number Analyzed 51 participants 15 participants
Yes - Independently
32
  62.7%
8
  53.3%
Yes - with assistance
19
  37.3%
6
  40.0%
No
0
   0.0%
1
   6.7%
96 Hours - Able to walk Number Analyzed 51 participants 15 participants
Yes - Independently
26
  51.0%
7
  46.7%
Yes - with assistance
21
  41.2%
7
  46.7%
No
4
   7.8%
1
   6.7%
96 Hours - Right shoulder flexion movement Number Analyzed 51 participants 15 participants
Yes - Independently
39
  76.5%
11
  73.3%
Yes - with assistance
11
  21.6%
4
  26.7%
No
1
   2.0%
0
   0.0%
96 Hours - Left shoulder flexion movement Number Analyzed 51 participants 15 participants
Yes - Independently
43
  84.3%
13
  86.7%
Yes - with assistance
6
  11.8%
2
  13.3%
No
2
   3.9%
0
   0.0%
120 Hours - Able to sit up in bed Number Analyzed 42 participants 10 participants
Yes - Independently
36
  85.7%
7
  70.0%
Yes - with assistance
6
  14.3%
3
  30.0%
No
0
   0.0%
0
   0.0%
120 Hours - Able to stand up Number Analyzed 42 participants 10 participants
Yes - Independently
30
  71.4%
5
  50.0%
Yes - with assistance
12
  28.6%
5
  50.0%
No
0
   0.0%
0
   0.0%
120 Hours - Able to walk Number Analyzed 42 participants 10 participants
Yes - Independently
23
  54.8%
5
  50.0%
Yes - with assistance
17
  40.5%
5
  50.0%
No
2
   4.8%
0
   0.0%
120 Hours - Right shoulder flexion movement Number Analyzed 42 participants 10 participants
Yes - Independently
34
  81.0%
9
  90.0%
Yes - with assistance
8
  19.0%
1
  10.0%
No
0
   0.0%
0
   0.0%
120 Hours - Left shoulder flexion movement Number Analyzed 42 participants 10 participants
Yes - Independently
37
  88.1%
10
 100.0%
Yes - with assistance
5
  11.9%
0
   0.0%
No
0
   0.0%
0
   0.0%
Discharge - Able to sit up in bed Number Analyzed 60 participants 19 participants
Yes - Independently
53
  88.3%
19
 100.0%
Yes - with assistance
7
  11.7%
0
   0.0%
No
0
   0.0%
0
   0.0%
Discharge - Able to stand up Number Analyzed 60 participants 19 participants
Yes - Independently
51
  85.0%
17
  89.5%
Yes - with assistance
7
  11.7%
2
  10.5%
No
2
   3.3%
0
   0.0%
Discharge - Able to walk Number Analyzed 60 participants 19 participants
Yes - Independently
50
  83.3%
15
  78.9%
Yes - with assistance
8
  13.3%
4
  21.1%
No
2
   3.3%
0
   0.0%
Discharge - Right shoulder flexion movement Number Analyzed 60 participants 19 participants
Yes - Independently
54
  90.0%
16
  84.2%
Yes - with assistance
6
  10.0%
3
  15.8%
No
0
   0.0%
0
   0.0%
Discharge - Left shoulder flexion movement Number Analyzed 60 participants 19 participants
Yes - Independently
51
  85.0%
16
  84.2%
Yes - with assistance
5
   8.3%
3
  15.8%
No
4
   6.7%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 48 Hours Post-Op: Patient able to sit up in bed
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2877
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 48 Hours Post-Op: Patient able to stand up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5311
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 48 Hours Post-Op: Patient able to walk
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4908
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 48 Hours Post-Op: Right Shoulder Flexion Movement
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8621
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 48 Hours Post-Op: Left Shoulder Flexion Movement
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 72 Hours Post-Op: Patient able to sit up in bed
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0133
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 72 Hours Post-Op: Patient able to stand up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0037
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 72 Hours Post-Op: Patient able to walk
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1671
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 72 Hours Post-Op: Right Shoulder Flexion Movement
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 72 Hours Post-Op: Left Shoulder Flexion Movement
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 96 Hours Post-Op: Patient able to sit up in bed
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 96 Hours Post-Op: Patient able to stand up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2757
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 96 Hours Post-Op: Patient able to walk
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9025
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 96 Hours Post-Op: Right Shoulder Flexion Movement
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7942
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 96 Hours Post-Op: Left Shoulder Flexion Movement
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 120 Hours Post-Op: Patient able to sit up in bed
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3492
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 120 Hours Post-Op: Patient able to stand up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2644
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 120 Hours Post-Op: Patient able to walk
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8258
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 120 Hours Post-Op: Right Shoulder Flexion Movement
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments 120 Hours Post-Op: Left Shoulder Flexion Movement
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5693
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments Discharge: Patient able to sit up in bed
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1189
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments Discharge: Patient able to stand up
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments Discharge: Patient able to walk
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6992
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments Discharge: Right Shoulder Flexion Movement
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4429
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Cryoanalgesia + SOC, Standard of Care
Comments Discharge: Left Shoulder Flexion Movement
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4563
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Adverse event data was captured over the entirety of the study, starting at the Baseline Visit and ending at the 6 Month Visit, which was the study exit visit.
Adverse Event Reporting Description The Investigator at each participating site was responsible for reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) to AtriCure only when they were related to the CryoAnalgesia index procedure or device, therefore access to all adverse events is not possible. All AEs reported to AtriCure (i.e., AEs related to the CryoAnalgesia procedure or device) will be reported.
 
Arm/Group Title Cryoanalgesia + SOC Standard of Care
Hide Arm/Group Description

Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.

Cryoanalgesia: AtriCure® cryoICE cryo-ablation system

Standard of Care: Institutional SOC for pain management will be followed.

Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.

Standard of Care: Institutional SOC for pain management will be followed.

All-Cause Mortality
Cryoanalgesia + SOC Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   8/65 (12.31%)      1/19 (5.26%)    
Hide Serious Adverse Events
Cryoanalgesia + SOC Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/65 (0.00%)      0/19 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cryoanalgesia + SOC Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/65 (3.08%)      0/19 (0.00%)    
Musculoskeletal and connective tissue disorders     
Right Breast Pain/Numbness  1  1/65 (1.54%)  1 0/19 (0.00%)  0
Hyperesthesia  1  1/65 (1.54%)  1 0/19 (0.00%)  0
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
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: Nfii Ndikitum
Organization: AtriCure
Phone: 513-644-8192
EMail: nndikintum@atricure.com
Publications:
Layout table for additonal information
Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT02922153    
Other Study ID Numbers: CP2015-4
First Submitted: September 26, 2016
First Posted: October 4, 2016
Results First Submitted: June 2, 2020
Results First Posted: September 4, 2020
Last Update Posted: September 4, 2020