CoolSculpting the Flank Using an Applicator With a Crown Cooling Insert
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Body Fat Disorder
- Sponsor
- Zeltiq Aesthetics
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Percentage of Correctly Identified Pre-treatment Photos by a Panel of Blinded Independent Reviewers
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flank using an applicator with and without the Crown Cooling Insert.
Detailed Description
This study will evaluate the Zeltiq CoolSculpting System when used with the standard CoolCore applicator and the CoolCore Applicator and the Crown Cooling Insert accessory.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects \> 22 years of age and \< 65 years of age.
- •Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
- •No weight change exceeding 5% of body weight in the preceding month.
- •Subject with body mass index (BMI) up to
- •BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- •Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study.
- •Subject has read and signed the study written informed consent form.
- •Exclusion Criteria
- •Subject has had a surgical procedure(s) in the area of intended treatment.
- •Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Correctly Identified Pre-treatment Photos by a Panel of Blinded Independent Reviewers
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 will be defined as at least 70% correct identification of the pre-treatment images for flanks treated with each treatment parameter by at least 2 of 3 reviewers.
Safety of the Zeltiq CoolSculpting System Using the CoolCore Applicator With and Without the Crown Cooling Insert
Time Frame: Enrollment through the 12 week post-treatment follow-up visit
The safety endpoint is the number of unanticipated adverse device effects (UADE) as well as the number of device and/or procedure-related adverse events. Adverse events are collected from the time of enrollment through the 12 week final follow-up visit.
Secondary Outcomes
- Subject Satisfaction(12 weeks post-treatment)