Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction

Not Applicable

Completed

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

• Registration Number: NCT01728857
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the outcome of non-invasive fat reduction using the ZELTIQ System.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-20
• Primary Completion: 2014-03-10
• Study Completion: 2014-03-10
• Results First Submitted: 2025-02-17
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Results First Posted: 2025-03-19
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 System	-

Primary Outcome Measures

Name	Time	Method
Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel	Baseline, Week 16	Photographs of the treatment areas were taken at baseline, and at 16-weeks after the first treatment with the ZELTIQ System were assessed for any visual changes. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 16-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound	Baseline, Week 16

Trial Locations

Locations (1)

Innovation Research Center; 🇺🇸 Pleasanton, California, United States