Non-Invasive Fat Reduction in the Chin Using Cryolipolysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Body Fat Disorder
- Sponsor
- Zeltiq Aesthetics
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Proportion of Accurately Identified Pre-Treatment Photos by a Panel of Blinded Independent Reviewers
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to further evaluate the safety and efficacy of non-invasive reduction of subcutaneous fat in the submental and submandibular area using Cryolipolysis.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Proportion of Accurately Identified Pre-Treatment Photos by a Panel of Blinded Independent Reviewers
Time Frame: Baseline (pre-treatment) and 12 weeks post 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, 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 by at least 70% correct identification of pre-treatment images by two out of three reviewers.
The Number of Unanticipated Adverse Device Effects (UADE) Reported
Time Frame: Enrollment through the 12 week final follow-up visit
The primary safety endpoint is the count of unanticipated adverse device effects (UADEs) reported in the study period. It is expected there will be zero UADEs.
Secondary Outcomes
- Subject Satisfaction(12 weeks post-treatment)
- Change in Fat Layer Thickness of the Submental Area as Measured by Caliper(Baseline and 12 week post-treatment)