MedPath

CoolSculpting the Upper Arm Study

Not Applicable
Completed
Conditions
Body Fat Disorder
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.

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
Primary Outcome Measures
NameTimeMethod
Percentage of Pre-treatment Images Correctly Identified12 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 Treatments12 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Dr. Jean Carruthers Cosmetic Surgery Inc.

🇨🇦

Vancouver, British Columbia, Canada

Pacific Dermaesthetics

🇨🇦

Vancouver, British Columbia, Canada

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.