CoolSculpting in the Abdomen Using Applicator With and Without CCI

Not Applicable

Completed

• Conditions: Body Fat Disorder

• Registration Number: NCT02787850
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the abdomen using an applicator with the Crown Cooling Insert.

Detailed Description

Evaluation of CoolSculpting treatment in the abdomen using a vacuum applicator with an accessory insert.

Study Timeline

• Study Start: 2016-04-18
• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-01
• Primary Completion: 2016-08-31
• Study Completion: 2016-08-31
• Results First Submitted: 2020-08-10
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-09
• Results First Posted: 2021-03-01
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participants With Unanticipated Adverse Device Effects (UADE)	Enrollment through 12 weeks post-treatment	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.
Percentage of Accurately Identified Pre-treatment Photos	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 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.

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction Questionnaire	12 weeks post-final treatment	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.

Trial Locations

Locations (1)

Bowes Dermatology Group; 🇺🇸 Miami, Florida, United States