CoolSculpting System

Study Overview
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Brief Summary
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Evaluate the safety and efficacy of multiple, simultaneous CoolSculpting cycles for the purpose of non-invasive fat reduction.

Official Title
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Noninvasive Fat Reduction With the CoolSculpting System

Conditions
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Body Fat Disorder

Intervention / Treatment
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* Device: The ZELTIQ System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subject (healthy volunteer) has read and signed the study written informed consent form. Male or female ≥ 22 years and ≤65 years of age. Subject has clearly visible fat in one or more areas on the torso (abdomen, flank, back fat, bra fat), which in the investigator's opinion, may benefit from the treatment. Subject has not had weight change exceeding 5% of body weight in the preceding month. Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the study. Subject has a BMI ≤ 30 as determined at screening. Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods. Exclusion Criteria Subject has had a recent surgical procedure 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, paroxysmal cold hemoglobinuria, or cold agglutinin disease. Subject has a known sensitivity to cold, such as cold urticaria, Raynaud's disease, chilblains (pernio), 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 has a history of hernia in the area(s) to be treated. Subject is pregnant or intending to become pregnant during the study period (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 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: Fat Reduction<br>The treatments are designed to see if the fat can be reduced in the torso area with a new applicator design. | Device: The ZELTIQ System<br>* The CoolSculpting machine 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 |
| --- | --- | --- |
| Efficacy Endpoint: Independent Photo Review | Correct identification of pre-treatment vs. 12-week post-treatment images by at least two out of three blinded, independent reviewers. Success will be defined as at least 70% correct identification of the pre-treatment images. | one-month post final data collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Endpoint: AE's | The frequency of device and procedure-related adverse events (AEs), including device-related serious adverse events (SADEs), will be summarized. | one-month post final data collection |