Feasibility Study of a Belt Applicator

Study Overview
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Brief Summary
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Evaluate the safety and feasibility of non-invasive fat reduction in the outer thigh with a belt applicator. Applicator design and treatment parameters will be evaluated.

Detailed Description
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The Zeltiq CoolSculpting System technology for cold-assisted lipolysis will be used with a modified belt applicator for the reduction of fat on the outer thigh. This is an open label, interventional, non-randomized feasibility study.

Official Title
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Feasibility Study of a Belt Applicator for Non-Invasive Fat Reduction in the Outer Thigh

Conditions
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Body Fat Disorder

Intervention / Treatment
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* Device: The Zeltiq System with Modified Belt Applicator


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 intended treatment area (outer thighs), which in the investigator's opinion, may benefit from the treatment(s). 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 his/her 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 6 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 in the next 8 months. Subject is lactating or has been lactating in the past 6 months. 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outer Thigh CoolSculpting Treatment<br>Treatment with the CoolSculpting System and a modified belt applicator will be performed on one outer thigh; the remaining thigh is considered the untreated control. Subjects will receive one cooling cycle applied to the thigh area intended for treatment with a protocol-defined cooling rate and duration of 120 minutes. | Device: The Zeltiq System with Modified Belt Applicator<br>* Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.<br>* Other names: Cryolipolysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Fat Layer of the Treated Area as Measured by Ultrasound The Change in Fat Layer Thickness in the Treated Outer Thigh | For each subject, ultrasound measurements will be obtained from the treated area and the contralateral untreated control area. The change in fat layer thickness in the untreated control thigh between baseline and 16 weeks will be used to account for variation in subject body weight during the study. The fat layer thickness change in the treated area will be normalized by subtracting the change in the untreated control thigh to remove the influence of subject weight variations. The normalized value will be used to evaluate success. The result is considered the treatment effect, an absolute change, and is reported as a mean change for the study population in centimeters of fat layer reduction. | Baseline to 16 weeks post-final treatment | 
| Safety of the Zeltiq System and Procedure | The number of device- and/or procedure related adverse events will be tabulated. Adverse event reports are collected throughout the study from the time of enrollment through the final 16 week follow-up visit. Investigators will determine whether an adverse event has a relationship to the study device or procedure. | Study enrollment through 16 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Correct Identification of Pre-treatment Photos | 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 (pre-treatment) 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. | Baseline and 16 weeks post-final treatment | 
| Percentage of Participants With Satisfaction on Questionnaire Questions | Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment. The questionnaire was composed of 5-point Likert scale questions, as well as free text responses. Each question offered five choices, ranging from very favorable, somewhat favorable, neutral/not sure, unfavorable and very unfavorable 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