The purpose of this study is to compare the performance of the Zeltiq CoolSculpting System using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.
The purpose of this study is to compare the performance of a cryolipolysis system using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Marina Plastic Surgery
Marina del Rey, California, United States
Innovation Research Center
Pleasanton, California, United States
Safety of the Zeltiq Device
The number of device- or procedure-related adverse events will be tabulated from the time of enrollment through the 16 week follow-up visit.
Time frame: Time of enrollment though16 weeks post-treatment (approximately 5 months)
Safety of the Zeltiq Device
The number of unanticipated adverse device effects (UADEs) will be tabulated.
Time frame: From enrollment through 16 week follow-up (approximately 5 months)
Percentage of Pre-treatment Images Correctly Identified.
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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 80%.
Time frame: Baseline and 16 weeks post-treatment
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control (untreated area) from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control. Results indicate the mean fat layer reduction in mm.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 16 weeks post-treatment
Subject Satisfaction
Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit. The questionnaire is composed of a 5-point Likert scale questions, as well as free text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither unsatisfied or satisfied; 4) somewhat satisfied; 5) very satisfied.
Time frame: 16-weeks post treatment