Non-Invasive Reduction of Abdominal Fat

Study Overview
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Brief Summary
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This study is being performed to reduce unwanted abdominal fat using a new applicator for the Zeltiq System.

Detailed Description
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The primary objective of the study is to achieve a discernable change to the contour of the abdominal area treated with the JUNO applicator that is consistent with that documented during a clinical study of a previous applicator used to treat lovehandles.

Official Title
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Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator

Conditions
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Fat Reduction

Intervention / Treatment
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* Device: The Zeltiq System


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 abdomen. Subject has not had weight change exceeding 10 pounds in the preceding month. Subject agrees to maintain their weight (i.e., within 5 pounds) by not making any major changes in their 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 in the past 6 months. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year. Subject has had a non-invasive fat reduction procedure in the area of intended treatment within the past 6 months. Subject 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 Reynaud'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 body mass index (BMI) exceeds 40. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. Subject is taking or has taken diet pills or supplements within the past month. Subject has any dermatological conditions or scars in the location of the treatment sites that may interfere with the treatment or evaluation. Subject is pregnant or intending to become pregnant in the next 6 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

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: Experimental: Abdomen Treatment Group<br>All subjects were treated on the abdomen with the CoolSculpting system. | Device: The Zeltiq System<br>* Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.<br>* Other names: Lipolysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion 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. 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 photos for each subject photo series and record selections on a data collection form. The expected success rate is an average 80% correct identification by the three reviewers. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Fat Layer of the Treated Area as Measured by Ultrasound | Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control from the change in treated area to remove the influence of weight variations. Results indicate the fat layer reduction in mm. | 16 weeks | 
| Subject Satisfaction | Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipolysis, Cryolipolysis, Fat Reduction