CoolSculpting the Flanks

Not Applicable

• Conditions: Body Fat Disorder

• 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

Study Timeline

• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-09
• Study Start: 2017-10-25
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-14
• Last Update Posted: 2020-08-18
• Primary Completion: 2022-08
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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)

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

Zel Skin & Laser Specialist; 🇺🇸 Edina, Minnesota, United States

Laser & Skin Surgery Center of New York; 🇺🇸 New York, New York, United States

Brian S. Biesman, MD; 🇺🇸 Nashville, Tennessee, United States

EpiCenter Skincare and Laser Center; 🇺🇸 Dallas, Texas, United States