CoolSculpting Treatment in the Upper Arms

Not Applicable

Completed

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

• Registration Number: NCT02939105
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum applicators for non-invasive subcutaneous fat reduction of the upper arms.

Detailed Description

Subcutaneous fat reduction of the upper arms using 2 vacuum applicator types will be done concurrently, such that a subject will have an applicator placed on each arm simultaneously.

Study Timeline

• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-19
• Study Start: 2016-12-02
• Primary Completion: 2017-03-03
• Study Completion: 2017-03-03
• Results First Submitted: 2020-08-10
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-13
• Last Update Submitted: 2021-05-13
• Results First Posted: 2021-06-09
• Last Update Posted: 2021-06-09

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
CoolSculpting Treatment in the Upper Arm	The ZELTIQ CoolSculpting System	Subjects in the study were treated with the CoolSculpting System with one of two vacuum applicator types for bilateral fat reduction in the upper arms. Applicators were used concurrently, with an applicator on each arm. Each subject received 1 or 2 cooling cycles on each arm for 35 minutes at protocol-defined temperatures. The Investigator selected the applicator for each subject based on the intended fat volume of the treatment area.

Primary Outcome Measures

Name	Time	Method
Proportion of Correctly Identified Pre-treatment Photos	12 weeks post-final 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 are practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images are 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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 70% correct identification by 2 out of 3 reviewers.
Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms	Enrollment through12 weeks post-final treatment	The primary safety endpoint of the study is the incidence of unanticipated adverse device effects (UADE) reported in the study period. Investigators assessed each adverse event to determine if there was relationship to the study device or procedure. Adverse event data are collected from the time of study enrollment through the final follow-up visit at 12 weeks post-treatment.

Trial Locations

Locations (1)

Pacific Dermaesthetics; 🇨🇦 Vancouver, British Columbia, Canada