Non-Invasive Reduction of Fat in the Inner Thighs

Not Applicable

Completed

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

• Registration Number: NCT01517659
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the ZELTIQ CoolSculpting System.

Detailed Description

The Zeltiq CoolSculpting System, which reduces subcutaneous fat in specific areas of the body, will be studied for safety and efficacy when used in the inner thigh.

Study Timeline

• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Study Start: 2012-12
• Primary Completion: 2014-02-12
• Study Completion: 2014-10
• Status Verified: 2020-08
• Results First Submitted: 2020-08-10
• Results First Submitted QC: 2020-10-23
• Results First Posted: 2020-11-17
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fat Reduction	The Zeltiq CoolSculpting System	The Zeltiq CoolSculpting System will be used to treat subcutaneous fat on each inner thigh.

Primary Outcome Measures

Name	Time	Method
Percentage of Pre-Treatment Images Correctly Identified by Reviewers	16 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. The expected success rate is at least 80% correct identification of pre-treatment images and the majority of physician reviewers (2 out 3) correctly identify 75% of the pre-treatment images.
Safety of the CoolSculpting Device and/or Procedure	Enrollment through 16 weeks post-treatment	The number of device- or procedure related adverse events will be tabulated. Adverse event data are collected continuously throughout the study period from the time of enrollment through the 16 week follow-up visit. At the time of an AE report, each study investigator determines the relationship to the investigational device or the study procedure.

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction	16 weeks post-treatment	Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment.
Reduction in Fat Layer Thickness in the Treated Area as Measured by Ultrasound	16 week-post-treatment	Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the untreated lateral thigh control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes will be normalized for each subject by subtracting the change in the control area from the change in treated area to remove the influence of weight variations. This result is considered the treatment effect. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control region. Results indicate the fat layer reduction in millimeters.

Trial Locations

Locations (3)

Zel Skin and Laser Specialists; 🇺🇸 Edina, Minnesota, United States

Laser & Skin Surgery Center of Northern California; 🇺🇸 Sacramento, California, United States

Dallas Plastic Surgery Institute; 🇺🇸 Dallas, Texas, United States