CoolSculpting of the Flank With Alternate Treatment Parameters

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction with an alternative treatment parameter.

Detailed Description
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The study evaluated the use of the Zeltiq CooSculpting System for non-invasive fat removal in the flank.

Official Title
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Non-Invasive Reduction of Subcutaneous Fat Layer With an Alternative Treatment Parameter

Conditions
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Body Fat Disorder

Intervention / Treatment
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* Device: The Zeltiq CoolSculpting System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Male or female subjects > 18 years of age and < 65 years of age. Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment. Subject has not had weight change exceeding 10 pounds in the preceding month. Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study. Subject has read and signed a written informed consent form. Exclusion Criteria Subject has had a surgical procedure(s) in the area of intended treatment. Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months. Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. Subject is taking or has taken diet pills or supplements within the past month. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion). Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system Subject is pregnant or intending to become pregnant during the study period (in the next 5 months). Subject is lactating or has been lactating in the past 6 months. Subject has a history of hernia in the areas to be treated. Subject is unable or unwilling to comply with the study requirements. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CoolSculpting of the Flank With Alternate Treatment Parameters<br>Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated. | Device: The Zeltiq CoolSculpting System<br>* Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.<br>* Other names: Lipolysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Device and/or Procedure-Related Adverse Events | 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. | Enrollment through 16 weeks post-treatment visit, which is approximately 5 months | 
| 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 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. | Pre-treatment and 16 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion 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. 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. | 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. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses. | 16 weeks post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipolysis, Cryolipolysis, Fat Reduction