CoolSculpting Treatment in the Upper Arms

Study Overview
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Brief Summary
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Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum applicators for non-invasive subcutaneous fat reduction of the upper arms.

Detailed Description
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Subcutaneous fat reduction of the upper arms using 2 vacuum applicator types will be done concurrently, such that a subject will have an applicator placed on each arm simultaneously.

Official Title
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DualSculpting the Upper Arms Using Vacuum Applicators and a Customized Treatment Approach

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 > 22 years of age and < 65 years of age. Subject has clearly visible fat sufficient for treatment on the upper arm, which in the investigator's opinion, may benefit from the treatment. No weight change exceeding 5% in the preceding month. Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study. Subject has read and signed the study written informed consent form. Exclusion Criteria History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or adjacent to the area of intended treatment. History of prior surgery in the arms. Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria. Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. History of carpal tunnel syndrome, compartment syndrome or deep vein thrombosis in the upper extremities. Currently taking or has taken diet pills or weight control supplements within the past month. Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation. Active implanted device such as a pacemaker, defibrillator, or drug delivery system. Pregnant or intending to become pregnant in the next 5 months. Lactating or has been lactating in the past 6 months. Unable or unwilling to comply with the study requirements. 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: 22 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 Treatment in the Upper Arm<br>Subjects in the study were treated with the CoolSculpting System with one of two vacuum applicator types for bilateral fat reduction in the upper arms. Applicators were used concurrently, with an applicator on each arm. Each subject received 1 or 2 cooling cycles on each arm for 35 minutes at protocol-defined temperatures. The Investigator selected the applicator for each subject based on the intended fat volume of the treatment area. | Device: The ZELTIQ CoolSculpting System<br>* The CoolSculpting device will be used to perform treatments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Correctly Identified 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. Reviewers are practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images are 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 70% correct identification by 2 out of 3 reviewers. | 12 weeks post-final treatment | 
| Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms | The primary safety endpoint of the study is the incidence of unanticipated adverse device effects (UADE) reported in the study period. Investigators assessed each adverse event to determine if there was relationship to the study device or procedure. Adverse event data are collected from the time of study enrollment through the final follow-up visit at 12 weeks post-treatment. | Enrollment through12 weeks post-final treatment |