Non-Invasive Reduction of Fat in the Flanks of Patients With Sharp Body Curvature
- Conditions
- Body Fat Disorder
- Interventions
- Device: The Zeltiq System
- Registration Number
- NCT01600638
- Lead Sponsor
- Zeltiq Aesthetics
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the ZELTIQ System and the CoolCurve+ applicator for non-invasive fat reduction in flanks for a patient population with sharp body curvature.
- Detailed Description
The Zeltiq System with the CoolCurve+ applicator will be evaluated for safety and effectiveness in subjects with subcutaneous fat on the flanks and who have sharp body curvatures. The curvature of interest is typical of individuals who are relatively thin with a small body frame.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zeltiq System Treatment Group The Zeltiq System Individuals with sharp flank curvatures were treated on one (1) flank with the Zeltiq CoolSculpting System and the CoolCurve+ applicator at protocol-defined temperatures and durations.
- Primary Outcome Measures
Name Time Method Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature. 8 weeks and 16 weeks post final treatment Safety will be assessed by determination of the number of Unanticipated Adverse Device Effects (UADE) at the 8-week and 16-week post-treatment visits.
Change in Fat Layer Thickness When Compared to Untreated Control 16 weeks post final 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 contralateral untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in the untreated control from the change in treated area to remove the influence of weight variations. Results indicate the mm of fat layer reduction in the treated area.
- Secondary Outcome Measures
Name Time Method Proportion of Pre-treatment Images Correctly Identified 16 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 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. Results reflect the proportion of correctly identified images.
Subject Satisfaction Questionnaire 16 weeks post final treatment Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit.
Additional Safety Evaluation Enrollment though 16 weeks post final treatment The number of device or procedure-related adverse events will be evaluated. The investigator determines if the Zeltiq CoolSculpting System (device) or the treatment (procedure) are related to all reported adverse events.
Trial Locations
- Locations (1)
Innovation Research Center
🇺🇸Pleasanton, California, United States