Pilot Study of Non-Invasive Fat Layer Reduction in the Flanks of Asian Patients With the CoolCurve+ Applicator
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Body Fat Disorder
- Sponsor
- Zeltiq Aesthetics
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Proportion of Pre-treatment Images Correctly Identified
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study will evaluate CoolSculpting and the CoolCurve applicator for non-invasive fat reduction in the flanks with sharp body curvature.
Detailed Description
The purpose of this study is to evaluate the performance of the CoolCurve+ applicator for non-invasive fat layer reduction in flanks for Asian patient population.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Proportion of Pre-treatment Images Correctly Identified
Time Frame: Baseline and 12 weeks post-final treatment
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline and pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success is defined as 70% correct identification of pre-treatment images.
Safety of the CoolSculpting and the CoolCurve+ Applicator
Time Frame: Enrollment through 12 weeks post-final treatment
The number of device- or procedure-related adverse events will be tabulated for all AEs reported continuously throughout the study, from enrollment to the final 12 week follow-up visit.
Secondary Outcomes
- Operator Feedback(Pre-treatment/treatment day)
- Subject Satisfaction With the Procedure(12 weeks post final treatment)
- Change in the Fat Layer Thickness(Pre-treatment and 12 weeks post-final treatment)