CoolSculpting the Flanks
- Conditions
- Body Fat Disorder
- Interventions
- Device: The ZELTIQ System
- Registration Number
- NCT03304925
- Lead Sponsor
- Zeltiq Aesthetics
- Brief Summary
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flanks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 320
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fat Reduction The ZELTIQ System The treatments are designed to see if the fat can be reduced in the flanks with a new applicator design.
- Primary Outcome Measures
Name Time Method Effectiveness endpoint gauged by reduction in fat layer thickness Final post-treatment visit Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
Safety endpoint in relation to adverse events Final post treatment visit Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
- Secondary Outcome Measures
Name Time Method Subject survey Final post-treatment visit Subject survey as assessed by questionnaire administered at the final post-treatment visit.
Photo review Final post-treatment visit Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.
Trial Locations
- Locations (7)
Zel Skin & Laser Specialist
🇺🇸Edina, Minnesota, United States
Innovation Research Center
🇺🇸Pleasanton, California, United States
Laser & Skin Surgery Center of Northern California
🇺🇸Sacramento, California, United States
SkinCare Physicians of Chestnut Hill
🇺🇸Chestnut Hill, Massachusetts, United States
Laser & Skin Surgery Center of New York
🇺🇸New York, New York, United States
EpiCenter Skincare and Laser Center
🇺🇸Dallas, Texas, United States
Brian S. Biesman, MD
🇺🇸Nashville, Tennessee, United States