CoolSculpting of the Flank With Alternate Treatment Parameters
- Conditions
- Body Fat Disorder
- Interventions
- Device: The Zeltiq CoolSculpting System
- Registration Number
- NCT02081196
- Lead Sponsor
- Zeltiq Aesthetics
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction with an alternative treatment parameter.
- Detailed Description
The study evaluated the use of the Zeltiq CooSculpting System for non-invasive fat removal in the flank.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CoolSculpting of the Flank With Alternate Treatment Parameters The Zeltiq CoolSculpting System Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated.
- Primary Outcome Measures
Name Time Method The Number of Device and/or Procedure-Related Adverse Events Enrollment through 16 weeks post-treatment visit, which is approximately 5 months The number of device- or procedure-related adverse events will be tabulated. Adverse event reports are collected throughout the study from enrollment through the 16 week follow-up visit. The investigator determines if there is a relationship between the event and the study device or procedure.
Change in the Fat Layer of the Treated Area as Measured by Ultrasound Pre-treatment and 16 weeks 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 contralateral flank 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 control from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated flank as compared to the untreated control flank. Results indicate the fat layer reduction in millimeters.
- Secondary Outcome Measures
Name Time Method Proportion of Pre-treatment Images Correctly Identified. 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. Images show both treated and untreated flanks. Reviewers will be practicing dermatologists or plastic surgeons. 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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatments; subject has complete set of baseline photos and post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 80% correct identification.
Subject Satisfaction 16 weeks post-treatment Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses.
Trial Locations
- Locations (3)
Laser & Skin Surgery Center of Northern California
🇺🇸Sacramento, California, United States
Dallas Plastic Surgery Institute
🇺🇸Dallas, Texas, United States
Arbutus Laser Centre
🇨🇦Vancouver, British Columbia, Canada