Non-Invasive Reduction of Fat in the Flanks of Patients With Sharp Body Curvature
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Body Fat Disorder
- Sponsor
- Zeltiq Aesthetics
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the ZELTIQ System and the CoolCurve+ applicator for non-invasive fat reduction in flanks for a patient population with sharp body curvature.
Detailed Description
The Zeltiq System with the CoolCurve+ applicator will be evaluated for safety and effectiveness in subjects with subcutaneous fat on the flanks and who have sharp body curvatures. The curvature of interest is typical of individuals who are relatively thin with a small body frame.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature.
Time Frame: 8 weeks and 16 weeks post final treatment
Safety will be assessed by determination of the number of Unanticipated Adverse Device Effects (UADE) at the 8-week and 16-week post-treatment visits.
Change in Fat Layer Thickness When Compared to Untreated Control
Time Frame: 16 weeks post final 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 contralateral untreated 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 the untreated control from the change in treated area to remove the influence of weight variations. Results indicate the mm of fat layer reduction in the treated area.
Secondary Outcomes
- Proportion of Pre-treatment Images Correctly Identified(16 weeks post final treatment)
- Subject Satisfaction Questionnaire(16 weeks post final treatment)
- Additional Safety Evaluation(Enrollment though 16 weeks post final treatment)