DualSculpting the Abdomen Using CoolSculpting

Not Applicable

Completed

• Conditions: Body Fat Disorder
• Interventions: Device: The ZELTIQ System

• Registration Number: NCT02941146
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

Evaluate the safety and efficacy of abdominal DualSculpting with CoolAdvantage applicators.

Detailed Description

The study will evaluate the safety and efficacy of non-invasive fat reduction in the abdomen using two applicators.

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-21
• Primary Completion: 2017-03-29
• Study Completion: 2017-03-29
• Results First Submitted: 2020-11-24
• Results First Submitted QC: 2020-11-24
• Results First Posted: 2020-12-21
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zeltiq Dual Sculpting Treatment Group	The ZELTIQ System	All subjects treated with CoolSculpting System using the CoolAdvantage and CoolAdvantage Plus applicators simultaneously on the abdomen.

Primary Outcome Measures

Name	Time	Method
Proportion of Correctly Identified Photos by Blinded Reviewers	Baseline to 12 weeks post-treatment	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.
Safety of the Zeltiq Device	12 week post-treatment	The incidence of unanticipated adverse device effects will be measured. It is expected there will be zero UADEs.

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction	12 weeks post-treatment	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.

Trial Locations

Locations (1)

Main Line Center for Laser Surgery; 🇺🇸 Ardmore, Pennsylvania, United States