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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
19
The CoolSculpting device and CoolCore applicator with and without the Crown Cooling Insert will be used to perform the treatments.
Laser and Skin Surgery of Northern California
Sacramento, California, United States
Percentage of Correctly Identified Pre-treatment Photos by a Panel of Blinded Independent Reviewers
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.
Time frame: 12 weeks post-treatment
Safety of the Zeltiq CoolSculpting System Using the CoolCore Applicator With and Without the Crown Cooling Insert
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.
Time frame: Enrollment through the 12 week post-treatment follow-up visit
Subject Satisfaction
Subject satisfaction as assessed by questionnaire administered at 12 weeks post-treatment. The questionnaire will consist of a 5-point Likert scale with the following selections options: 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither satisfied nor unsatisfied; 4) somewhat satisfied; 5) very satisfied. jIn addition, free-text fields provided options for subjects responses.
Time frame: 12 weeks post-treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.