Pilot Study on The Flanks of Asian Patients
- Conditions
- Body Fat Disorder
- Interventions
- Device: The Zeltiq System
- Registration Number
- NCT01623037
- Lead Sponsor
- Zeltiq Aesthetics
- Brief Summary
This study will evaluate CoolSculpting and the CoolCurve applicator for non-invasive fat reduction in the flanks with sharp body curvature.
- Detailed Description
The purpose of this study is to evaluate the performance of the CoolCurve+ applicator for non-invasive fat layer reduction in flanks for Asian patient population.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CoolSculpting Treatment Group The Zeltiq System The single arm will include all subjects treated on each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol.
- Primary Outcome Measures
Name Time Method Proportion of Pre-treatment Images Correctly Identified Baseline and 12 weeks post-final 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 and 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 70% correct identification of pre-treatment images.
Safety of the CoolSculpting and the CoolCurve+ Applicator Enrollment through 12 weeks post-final treatment The number of device- or procedure-related adverse events will be tabulated for all AEs reported continuously throughout the study, from enrollment to the final 12 week follow-up visit.
- Secondary Outcome Measures
Name Time Method Operator Feedback Pre-treatment/treatment day Operator performing or assisting with study procedure will complete two questionnaire at the treatment visit regarding the fit of two applicators: 1) CoolCurve+ and 2) CoolCurve The questionnaire consists of four multiple choice questions, each having a 5-point scale, with '5' representing the best and '1' the worst.
Subject Satisfaction With the Procedure 12 weeks post final treatment Subject satisfaction as assessed by questionnaire administered at 12-weeks post-treatment will be tabulated. The questionnaire will be composed of 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 nor satisfied; 4) somewhat satisfied; 5) very satisfied.
Change in the Fat Layer Thickness Pre-treatment and 12 weeks post-final treatment Caliper measurements will be obtained prior to treatment and at the 12-week follow-up visit to assess for changes to the fat layers in the flanks. After the treatment area is identified and marked, the thickness of fat layer will be measured using a caliper at the middle of the fat bulge. For each treatment area, three (3) measurements will be taken and recorded. The average of the three measurements will be calculated. The location of where measurements were taken will be recorded on a transparency sheet along with reference points using the subject's body landmarks (such as a mole, skin pigmentation). This transparency will be used at post treatment visit to locate the measurement sites. Results will be reported in millimeters of fat layer.
Trial Locations
- Locations (1)
Hong Kong Dermatology and Laser Centre
🇨🇳Hong Kong, Hong Kong, China