Non-invasive Cooling of Subcutaneous Fat

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.

Detailed Description
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The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat using the Zeltiq Dermal Cooling device.

Official Title
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A Prospective, Multi-Center Clinical Study of Non-Invasive Cooling of Subcutaneous Fat

Conditions
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Fat Disorder

Intervention / Treatment
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* Device: Zeltiq Dermal Cooling Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects > 18 years of age. Subject has clearly visible fat on the flanks, thighs, abdomen, or back. Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month. Subject has read and signed a written informed consent form. Exclusion Criteria: Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. Subject is taking diet pills within the past 6 months. Subject is unable or unwilling to comply with the study requirements. Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. Patient is pregnant or intending to become pregnant in the next 9 months. Patient is lactating or has been lactating in the past 9 months. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 1<br>Cooling Intensity Factor = 33 Duration = 60 minutes | Device: Zeltiq Dermal Cooling Device<br>* Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.<br>|
| Experimental: Treatment Group 2<br>Cooling Intensity Factor = 37 Duration = 30 minutes | Device: Zeltiq Dermal Cooling Device<br>* Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.<br>|
| Experimental: Treatment Group 3<br>Cooling Intensity Factor = 37 Duration = 45 minutes | Device: Zeltiq Dermal Cooling Device<br>* Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.<br>|
| Experimental: Treatment Group 4<br>Cooling Intensity Factor = 42 Cooling Duration = 30 minutes | Device: Zeltiq Dermal Cooling Device<br>* Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fat Layer Thickness of the Treated Flank | The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group. | Baseline and 6 months | 
| Percentage of Subjects Expressing Satisfaction With the Procedure | Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits. | 6 months post-treatment follow-up visit | 
| Percentage of Correctly Identified Pre-treatment Photographs | Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. 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 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. Results reflect the percentage of correctly identified images. | Baseline and 6 months |