CoolSculpting the Upper Arm Study

Study Overview
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Brief Summary
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Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a specialized surface applicator for non-invasive subcutaneous fat reduction in the upper arm.

Detailed Description
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This multi-center trial will evaluate the Zeltiq CoolSculpting treatment to perform treatments in the upper arm for the reduction subcutaneous fat reduction.

Official Title
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CoolSculpting the Upper Arm Using a Vacuum Applicator

Conditions
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Body Fat Disorder

Intervention / Treatment
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* Device: CoolSculpting device with vacuum applicator.


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: Upper arm treatment with vacuum applicator<br>Subjects with clearly visible fat sufficient for treatment received bilateral CoolSculpting treatments, 1 treatment on each arm. | Device: CoolSculpting device with vacuum applicator.<br>* The CoolSculpting device with a vacuum applicator will be used to perform the treatments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage 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 of the treated areas. The review panel will consist of 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 photos for each subject photo series and record selections on a data collection form. Correct identification of photos by at least 2 of the 3 reviewers has an expected success rate of 75%. | 12 weeks post treatment | 
| Safety of the CoolSculpting Device in Upper Arm Treatments | The incidence of reported unanticipated adverse device effects (UADE) from the time of enrollment through the 12-week follow-up visit will be collected and analyzed. It is expected there will be zero UADE's reported. | 12 weeks post-treatment |