The Effects of Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Body Fat Disorder
- Sponsor
- Zeltiq Aesthetics
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound(Baseline, Week 16)