CoolSculpting the Abdomen Using an Applicator With a Crown Cooling Insert
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Body Fat Disorder
- Sponsor
- Zeltiq Aesthetics
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Participants With Unanticipated Adverse Device Effects (UADE)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the abdomen using an applicator with the Crown Cooling Insert.
Detailed Description
Evaluation of CoolSculpting treatment in the abdomen using a vacuum applicator with an accessory insert.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Participants With Unanticipated Adverse Device Effects (UADE)
Time Frame: Enrollment through 12 weeks post-treatment
The number of unanticipated device effects will be tabulated to assess safety of the device and applicator accessory (Crown Cooling Insert). Adverse event data is collected from the time of enrollment through the 12 week follow-up visit.
Percentage of Accurately Identified Pre-treatment Photos
Time Frame: 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 at least 70% correct identification of pre-treatment images by two out of three reviewers.
Secondary Outcomes
- Subject Satisfaction Questionnaire(12 weeks post-final treatment)