Trial Outcomes & Findings for CoolSculpting the Upper Arm Study (NCT NCT02669329)
NCT ID: NCT02669329
Last Updated: 2021-11-04
Results Overview
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. The review panel will consist of practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Correct identification of photos by at least 2 of the 3 reviewers has an expected success rate of 75%.
COMPLETED
NA
30 participants
12 weeks post treatment
2021-11-04
Participant Flow
Unit of analysis: arms
Participant milestones
| Measure |
Upper Arm Treatment Group
Each subject in the arm received bilateral treatment with the CoolSculpting device. Each arm was treated once.
|
|---|---|
|
Overall Study
STARTED
|
30 60
|
|
Overall Study
COMPLETED
|
30 60
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CoolSculpting the Upper Arm Study
Baseline characteristics by cohort
| Measure |
Upper Arm Treatment With Vacuum Applicator
n=30 Participants
The CoolSculpting device with vacuum applicator will be used to administer treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
30 Participants
n=5 Participants
|
|
Body Mass Index
|
28.2 kg//m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post treatmentPopulation: Thirty subjects received bilateral treatments to the upper arms. Three subjects did not maintain weight per-protocol requirements and were excluded from the primary efficacy analysis.
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. The review panel will consist of practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Correct identification of photos by at least 2 of the 3 reviewers has an expected success rate of 75%.
Outcome measures
| Measure |
Upper Arm Treatment With Vacuum Applicator
n=54 photo pairs reviewed
The CoolSculpting device with vacuum applicator will be used to administer treatment.
|
|---|---|
|
Percentage of Pre-treatment Images Correctly Identified
|
85.2 percent correctly identified images
Interval 72.9 to 93.4
|
PRIMARY outcome
Timeframe: 12 weeks post-treatmentPopulation: The analysis population consisted of subjects to whom treatment was administered and who completed the 12 week post-treatment visit.
The incidence of reported unanticipated adverse device effects (UADE) from the time of enrollment through the 12-week follow-up visit will be collected and analyzed. It is expected there will be zero UADE's reported.
Outcome measures
| Measure |
Upper Arm Treatment With Vacuum Applicator
n=30 Participants
The CoolSculpting device with vacuum applicator will be used to administer treatment.
|
|---|---|
|
Safety of the CoolSculpting Device in Upper Arm Treatments
|
0 UADEs reported
|
Adverse Events
Upper Arm Treatment With Vacuum Applicator
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Upper Arm Treatment With Vacuum Applicator
n=30 participants at risk
The CoolSculpting device with vacuum applicator will be used to administer treatment.
|
|---|---|
|
Nervous system disorders
Prolonged bilateral numbness
|
10.0%
3/30 • Number of events 6 • Enrollment through the 12 week follow-up visit.
|
|
Nervous system disorders
Tingling outside of treatment area
|
3.3%
1/30 • Number of events 1 • Enrollment through the 12 week follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.3%
1/30 • Number of events 2 • Enrollment through the 12 week follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Prolonged unilateral numbness
|
3.3%
1/30 • Number of events 1 • Enrollment through the 12 week follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Numbness
|
3.3%
1/30 • Number of events 1 • Enrollment through the 12 week follow-up visit.
|
|
General disorders
Stomach flu
|
3.3%
1/30 • Number of events 1 • Enrollment through the 12 week follow-up visit.
|
|
General disorders
Cold symptoms
|
6.7%
2/30 • Number of events 2 • Enrollment through the 12 week follow-up visit.
|
Additional Information
Kerrie Jiang, Executive Director, Regulatory, Clinical and Medical Affairs
Zeltiq Aesthetics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place