Trial Outcomes & Findings for CoolSculpting in the Abdomen Using Applicator With and Without CCI (NCT NCT02787850)

Last Updated: 2021-12-03

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 is defined as at least 70% correct identification of pre-treatment images by two out of three reviewers.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

12 weeks post treatment

Results posted on

2021-12-03

Participant Flow

Subjects seeking reduction of fat in the abdomen were recruited from the general population.

Participant milestones

Participant milestones
Measure	CoolSculpting Treatment Cohort A CoolSculpting device with and without Crown Cooling Insert and standard applicator and will be used to perform treatments on contralateral sides of the abdomen. Cohort A will receive treatments on one side of the abdomen without the Crown Cooling Insert with a protocol-defined temperature for 60 minutes. The contralateral side of the abdomen will be treated with the Crown Cooling Insert using a protocol-defined temperature for 45 minutes.	CoolSculpting Treatment Cohort B CoolSculpting device with the Crown Cooling Insert and standard applicator and will be used to perform treatments on contralateral sides of the abdomen. Cohort B subjects will be treated one one half of the abdomen with the Crown Cooling Insert at a protocol-defined temperature for 45 minutes. The contralateral side of the abdomen will also be treated with the Cron Cooling Insert at a protocol-defined temperature for 60 minutes.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	CoolSculpting Treatment Cohort A CoolSculpting device with and without Crown Cooling Insert and standard applicator and will be used to perform treatments on contralateral sides of the abdomen. Cohort A will receive treatments on one side of the abdomen without the Crown Cooling Insert with a protocol-defined temperature for 60 minutes. The contralateral side of the abdomen will be treated with the Crown Cooling Insert using a protocol-defined temperature for 45 minutes.	CoolSculpting Treatment Cohort B CoolSculpting device with the Crown Cooling Insert and standard applicator and will be used to perform treatments on contralateral sides of the abdomen. Cohort B subjects will be treated one one half of the abdomen with the Crown Cooling Insert at a protocol-defined temperature for 45 minutes. The contralateral side of the abdomen will also be treated with the Cron Cooling Insert at a protocol-defined temperature for 60 minutes.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

CoolSculpting in the Abdomen Using Applicator With and Without CCI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CoolSculpting Treatment Cohort A n=10 Participants The treatments are designed to see if fat can be reduced in the abdomen with an applicator design incorporating a new insert. Treatment duration and cooling will vary between treatment sites and cohorts. The CoolSculpting device will be used to perform treatments.	CoolSculpting Treatment Cohort B n=10 Participants The treatments are designed to see if fat can be reduced in the abdomen with an applicator design incorporating a new insert. Treatment duration and cooling will vary between treatment sites and cohorts. The CoolSculpting device will be used to perform treatments.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants	10 Participants n=4 Participants	20 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	44.4 years n=93 Participants	36.2 years n=4 Participants	40.3 years n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	10 Participants n=93 Participants	10 Participants n=4 Participants	20 Participants n=27 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	10 Participants n=93 Participants	10 Participants n=4 Participants	20 Participants n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks post treatment

Population: The analysis population consisted of 19 subjects with evaluable images. Six images from each subject's abdomen were reviewed by the independent reviewers.

Outcome measures

Outcome measures
Measure	Overall Study Population-Both Cohorts n=38 photos The analysis population included subjects enrolled in both cohorts of the study.	Abdomen Site Treated Using CCI for 60 Minutes and Warmer Temperature n=30 photos The abdomen was treated for a duration of 60 minutes per a protocol-defined temperature using the CCI applicator accessory.	Abdomen Sites Treated With CCI for 45 Minutes n=57 photos 1 side of the abdomen was treated for 45 minutes at a protocol defined temperature with the CCI applicator accessory.	Abdomen Site Treated for 60 Minutes n=27 photos One abdomen site was treated with a lower protocol-defined temperature for 60 minutes with the CCI accessory.
Percentage of Accurately Identified Pre-treatment Photos	33 photos	23 photos	50 photos	23 photos

PRIMARY outcome

Timeframe: Enrollment through 12 weeks post-treatment

Population: Subjects who received CoolSculpting treatment for reduction of subcutaneous fat in the abdomen were included in the analysis population. Of the 20 subjects enrolled and treated, one subject withdrew prior to study completion.

The number of unanticipated device effects will be tabulated to assess safety of the device and applicator accessory (Crown Cooling Insert). Adverse event data is collected from the time of enrollment through the 12 week follow-up visit.

Outcome measures

Outcome measures
Measure	Overall Study Population-Both Cohorts n=10 Participants The analysis population included subjects enrolled in both cohorts of the study.	Abdomen Site Treated Using CCI for 60 Minutes and Warmer Temperature n=9 Participants The abdomen was treated for a duration of 60 minutes per a protocol-defined temperature using the CCI applicator accessory.	Abdomen Sites Treated With CCI for 45 Minutes 1 side of the abdomen was treated for 45 minutes at a protocol defined temperature with the CCI applicator accessory.	Abdomen Site Treated for 60 Minutes One abdomen site was treated with a lower protocol-defined temperature for 60 minutes with the CCI accessory.
Participants With Unanticipated Adverse Device Effects (UADE)	0 UADEs	0 UADEs	—	—

SECONDARY outcome

Timeframe: 12 weeks post-final treatment

Population: Groups include per-protocol subgroups for Cohort A and Cohort B. 20 subjects were assigned treatment parameters in Subgroup 2; one (1) subject withdrew from the study prior to completion.

Subject satisfaction with the treatment experience data will also be collected via a written questionnaire at the 12-week follow up visits. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be: 1) very satisfied; 2) somewhat satisfied; 3) neither satisfied nor unsatisfied; 4) somewhat unsatisfied; 5) very unsatisfied.

Outcome measures

Outcome measures
Measure	Overall Study Population-Both Cohorts n=10 Participants The analysis population included subjects enrolled in both cohorts of the study.	Abdomen Site Treated Using CCI for 60 Minutes and Warmer Temperature n=19 Participants The abdomen was treated for a duration of 60 minutes per a protocol-defined temperature using the CCI applicator accessory.	Abdomen Sites Treated With CCI for 45 Minutes n=9 Participants 1 side of the abdomen was treated for 45 minutes at a protocol defined temperature with the CCI applicator accessory.	Abdomen Site Treated for 60 Minutes One abdomen site was treated with a lower protocol-defined temperature for 60 minutes with the CCI accessory.
Subject Satisfaction Questionnaire Very visible to visible fat reduction	8 Participants	16 Participants	8 Participants	—
Subject Satisfaction Questionnaire Results expected or more than expected	7 Participants	14 Participants	7 Participants	—
Subject Satisfaction Questionnaire Satisfied to very satisfied with procedure	9 Participants	17 Participants	7 Participants	—

Adverse Events

Cohort A-Abdomen Side 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort A-Abdomen Side 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort B-Abdomen Side 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort B- Abdomen Side 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort A-Abdomen Side 1 n=10 participants at risk Cohort A will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 60 minutes without the Crown Cooling Insert.	Cohort A-Abdomen Side 2 n=10 participants at risk Abdomen side 2 will be treated using the CoolMax applicator and the Crown Cooling Insert for 45 minutes at a protocol-defined temperature.	Cohort B-Abdomen Side 1 n=10 participants at risk Cohort B will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 45 minutes with the CoolMax Applicator and Crown Cooling Insert.	Cohort B- Abdomen Side 2 n=10 participants at risk Abdomen side 2 will be treated with the CoolMAx applicator at a second protocol-defined temperature for 60 minutes, with the Crown Cooling Insert.
General disorders Pain	10.0% 1/10 • Number of events 1 • Adverse event data were collected from enrollment through the 12-week final follow-up visit. Adverse events (AE) will be assessed continuously throughout the study. An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.	0.00% 0/10 • Adverse event data were collected from enrollment through the 12-week final follow-up visit. Adverse events (AE) will be assessed continuously throughout the study. An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.	0.00% 0/10 • Adverse event data were collected from enrollment through the 12-week final follow-up visit. Adverse events (AE) will be assessed continuously throughout the study. An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.	0.00% 0/10 • Adverse event data were collected from enrollment through the 12-week final follow-up visit. Adverse events (AE) will be assessed continuously throughout the study. An adverse event is defined as any untoward medical occurrence in a subject, regardless of whether the event is related to the device.

Additional Information

Kerrie Jiang, Sr. Director of Clinical, Regulatory and Medical Affairs

Zeltiq Aesthetics

Phone: (925) 621-7462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place