CoolSculpting of the Flank With Alternate Treatment Parameters

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 untreated contralateral flank 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 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 flank as compared to the untreated control flank. Results indicate the fat layer reduction in millimeters.

Time frame: Pre-treatment and 16 weeks post-treatment

Population: Thirty-five subjects were included in the per-protocol analysis population: 1 subject was LTFU, 2 subjects did not complete the 16 week follow-up visit when ultrasonographer was present and 1 subject received an incomplete treatment. Six additional subjects had weight change greater than the protocol defined 5 pounds at the final follow-up visit.

The number of device- or procedure-related adverse events will be tabulated. Adverse event reports are collected throughout the study from enrollment through the 16 week follow-up visit. The investigator determines if there is a relationship between the event and the study device or procedure.

Time frame: Enrollment through 16 weeks post-treatment visit, which is approximately 5 months

Population: The safety population includes all subjects treated with CoolSculpting.

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. Images show both treated and untreated flanks. Reviewers will be practicing dermatologists or plastic surgeons. 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 treatments; subject has complete set of baseline photos and post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 80% correct identification.

Time frame: 16 weeks post-treatment

Population: The study population consisted of 45 participants. 1 subject was lost to follow-up; 1 subject had an incomplete treatment and photos of 1 subject were poor quality. Of the remaining 42 subjects, 7 did not maintain weight per protocol. 35 sets of subject photos were included in the analysis. Each image showed both treated and untreated flanks; both arms were included in the photo review.

Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses.

Time frame: 16 weeks post-treatment

Population: Of the 45 study participants, one subject received incomplete treatment and did not complete the questionnaire and one subject was lost to follow-up. Free text responses and inconclusive responses were excluded from analysis.