CoolSculpting the Upper Arm Study

Not Applicable

Completed

• Conditions: Body Fat Disorder
• Interventions: Device: CoolSculpting device with vacuum applicator.

• Registration Number: NCT02669329
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a specialized surface applicator for non-invasive subcutaneous fat reduction in the upper arm.

Detailed Description

This multi-center trial will evaluate the Zeltiq CoolSculpting treatment to perform treatments in the upper arm for the reduction subcutaneous fat reduction.

Study Timeline

• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-02-01
• Study Start: 2016-02-05
• Primary Completion: 2016-06-07
• Study Completion: 2016-06-07
• Status Verified: 2020-08
• Results First Submitted: 2020-08-10
• Results First Submitted QC: 2020-08-28
• Results First Posted: 2020-09-17
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Upper arm treatment with vacuum applicator	CoolSculpting device with vacuum applicator.	Subjects with clearly visible fat sufficient for treatment received bilateral CoolSculpting treatments, 1 treatment on each arm.

Primary Outcome Measures

Name	Time	Method
Percentage of Pre-treatment Images Correctly Identified	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. The review panel will consist of 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. Correct identification of photos by at least 2 of the 3 reviewers has an expected success rate of 75%.
Safety of the CoolSculpting Device in Upper Arm Treatments	12 weeks post-treatment	The incidence of reported unanticipated adverse device effects (UADE) from the time of enrollment through the 12-week follow-up visit will be collected and analyzed. It is expected there will be zero UADE's reported.

Trial Locations

Locations (2)

Pacific Dermaesthetics; 🇨🇦 Vancouver, British Columbia, Canada

Dr. Jean Carruthers Cosmetic Surgery Inc.; 🇨🇦 Vancouver, British Columbia, Canada