Evaluate the performance of a cryolipolysis system using a colder treatment parameter for non-invasive reduction of subcutaneous fat in the lateral thighs.
Evaluation of the Zeltiq CoolSculpting System for non-invasive subcutaneous fat reduction in the lateral thighs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
The CoolSculpting System delivers non-invasive cooling for the reduction of subcutaneous fat.
Innovation Research Center
Pleasanton, California, United States
Safety of the Zeltiq CoolSculpting System in the Outer Thighs
Tabulation of device and/or procedure-related adverse events and unanticipated adverse device effects will be performed. Adverse event information will be collected from the time of study enrollment through the 12 week follow-up visit. The Investigator will determine if an adverse event is related to the device and/or study procedure.
Time frame: Enrollment through 12 week post-final treatment follow-up visit
Percentage of Correctly Identified Pre-treatment Photographs
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 2 out of 3 reviewers.
Time frame: 12 weeks post-final treatment
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