Trial Outcomes & Findings for DualSculpting the Abdomen Using CoolSculpting (NCT NCT02941146)

Last Updated: 2021-12-06

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. 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. The primary efficacy endpoint of the study was the correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment images by two out of three blinded, independent reviewers. Success was defined as at least 70% correct identification of the baseline (pre-treatment) photographs.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

Baseline to 12 weeks post-treatment

Results posted on

2021-12-06

Participant Flow

Protocol defined inclusion and exclusion conditions determined study entry. All subjects were included in the single arm study.

Participant milestones

Participant milestones
Measure	CoolSculpting of the Abdomen Non-invasive fat reduction of the abdomen will be performed using the Zeltiq CoolSculpting System.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DualSculpting the Abdomen Using CoolSculpting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CoolSculpting of the Abdomen With Dual Applicators n=15 Participants Non-invasive fat reduction of the abdomen was performed using the Zeltiq CoolSculpting System using dual applicators.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45.0 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	6 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 Hispanic	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	15 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants
Body Mass Index	29.5 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks post-treatment

Population: Fourteen of 15 treated subjects were included in the per-protocol analysis. One subject was excluded from analysis due to a protocol-defined weight maintenance requirement. Pre-treatment and post-treatment photos were evaluated by 3 independent physician reviewers.

Outcome measures

Outcome measures
Measure	CoolSculpting of the Abdomen With Dual Applicators n=42 photos Non-invasive fat reduction of the abdomen was performed using the Zeltiq CoolSculpting System using dual applicators.
Proportion of Correctly Identified Photos by Blinded Reviewers	28 photos

PRIMARY outcome

Timeframe: 12 week post-treatment

Population: The "as-treated" population included all subjects who were treated with CoolSculpting.

The incidence of unanticipated adverse device effects will be measured. It is expected there will be zero UADEs.

Outcome measures

Outcome measures
Measure	CoolSculpting of the Abdomen With Dual Applicators n=15 Participants Non-invasive fat reduction of the abdomen was performed using the Zeltiq CoolSculpting System using dual applicators.
Safety of the Zeltiq Device	0 device-or procedure-related AEs

SECONDARY outcome

Timeframe: 12 weeks post-treatment

Population: The per-protocol population consisted of 14 subjects. One subject was excluded for weight gain \>5%, a protocol defined limit for weight maintenance and was excluded from the analysis.

Subject satisfaction with the Zeltiq procedure as determined by positive responses in a subject satisfaction questionnaire administered at the 12 weeks post-treatment visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses, with lower numbers (e.g. 1 or 2) indicating positive responses and higher numbers indicating less positive responses.

Outcome measures

Outcome measures
Measure	CoolSculpting of the Abdomen With Dual Applicators n=14 Participants Non-invasive fat reduction of the abdomen was performed using the Zeltiq CoolSculpting System using dual applicators.
Subject Satisfaction Procedure comfortable/very comfortable	7 Participants
Subject Satisfaction Feel appearance improved	8 Participants
Subject Satisfaction Satisfied or very satisfied with procedure	9 Participants
Subject Satisfaction Would recommend to a friend	7 Participants

Adverse Events

CoolSculpting of the Abdomen With Dual Applicators

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: (925) 621-7462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place