Trial Outcomes & Findings for Bilateral; Flank Study With Crown Cooling Insert (NCT NCT02554760)
NCT ID: NCT02554760
Last Updated: 2020-10-26
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. Reviewers will be 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. Success will be defined as at least 70% correct identification of the pre-treatment images for flanks treated with each treatment parameter by at least 2 of 3 reviewers.
COMPLETED
NA
19 participants
12 weeks post-treatment
2020-10-26
Participant Flow
Subjects seeking a reduction in fat in the flank area were recruited from the general population.
Participant milestones
| Measure |
Left Side With Crown Cooling Insert, Right Side Std CoolCore
Crown Cooling Insert (CCI) used for treatment on left flank at protocol-defined temperature and duration. Right flank treated using standard CoolCore applicator at protocol-defined temperature and duration.
|
Left Side Std CoolCore, Right Side With Crown Cooling Insert
Left flank treated with standard CoolCore applicator at protocol-defined temperature and duration. Right side treated with Crown Cooling Insert at protocol-defined temperature and duration.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bilateral; Flank Study With Crown Cooling Insert
Baseline characteristics by cohort
| Measure |
CoolSculpting Treatment
n=19 Participants
The ZELTIQ CoolSculpting System: The CoolSculpting device and CoolCore applicator will be used to perform the treatments.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
|
Body Mass Index
|
25.3 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post-treatmentPopulation: All subjects received bilateral flank treatments.
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. Reviewers will be 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. Success will be defined as at least 70% correct identification of the pre-treatment images for flanks treated with each treatment parameter by at least 2 of 3 reviewers.
Outcome measures
| Measure |
CoolSculpting Treatment With Standard CoolCore Applicator
n=19 photos
19 subjects received treatment for 60 minutes in duration at a protocol-defined temperature on one flank.
|
CoolSculpting Treatment/ CoolCore Applicator Plus CCI
n=19 photos
19 subjects received treatment for a duration of 35 minutes at a protocol-defined temperature on the contralateral flank.
|
|---|---|---|
|
Percentage of Correctly Identified Pre-treatment Photos by a Panel of Blinded Independent Reviewers
|
16 photos
|
15 photos
|
PRIMARY outcome
Timeframe: Enrollment through the 12 week post-treatment follow-up visitPopulation: All 19 subjects were in the analysis group. Had there been any adverse events reported in the study period, each event would be categorized per intervention. However, there were zero adverse events reported for either of the two interventions and none reported for the study, therefore the arms were combined for the analysis.
The safety endpoint is the number of unanticipated adverse device effects (UADE) as well as the number of device and/or procedure-related adverse events. Adverse events are collected from the time of enrollment through the 12 week final follow-up visit.
Outcome measures
| Measure |
CoolSculpting Treatment With Standard CoolCore Applicator
n=19 Participants
19 subjects received treatment for 60 minutes in duration at a protocol-defined temperature on one flank.
|
CoolSculpting Treatment/ CoolCore Applicator Plus CCI
19 subjects received treatment for a duration of 35 minutes at a protocol-defined temperature on the contralateral flank.
|
|---|---|---|
|
Safety of the Zeltiq CoolSculpting System Using the CoolCore Applicator With and Without the Crown Cooling Insert
|
0 UADEs /device or procedure events
|
—
|
SECONDARY outcome
Timeframe: 12 weeks post-treatmentPopulation: The per-protocol population (19 subjects) was included in the analysis. Each subject received treatment on each flank; the standard CoolCore applicator was used on one flank and the contralateral flank was treated with the CoolCore with the Crown Cooling Insert.
Subject satisfaction as assessed by questionnaire administered at 12 weeks post-treatment. The questionnaire will consist of a 5-point Likert scale with the following selections options: 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither satisfied nor unsatisfied; 4) somewhat satisfied; 5) very satisfied. jIn addition, free-text fields provided options for subjects responses.
Outcome measures
| Measure |
CoolSculpting Treatment With Standard CoolCore Applicator
n=19 Participants
19 subjects received treatment for 60 minutes in duration at a protocol-defined temperature on one flank.
|
CoolSculpting Treatment/ CoolCore Applicator Plus CCI
n=19 Participants
19 subjects received treatment for a duration of 35 minutes at a protocol-defined temperature on the contralateral flank.
|
|---|---|---|
|
Subject Satisfaction
Treatment was comfortable to very comfortable
|
11 Participants
|
12 Participants
|
|
Subject Satisfaction
Very visible to somewhat visible fat reduction
|
10 Participants
|
10 Participants
|
|
Subject Satisfaction
Satisfied to very satisfied with procedure
|
13 Participants
|
12 Participants
|
Adverse Events
CoolSculpting Using Standard CoolCore
CoolSculpting Device Using Crown Cooling Insert
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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