CoolSculpting in the Abdomen Using Applicator With and Without CCI

Study Overview
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Brief Summary
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Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the abdomen using an applicator with the Crown Cooling Insert.

Detailed Description
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Evaluation of CoolSculpting treatment in the abdomen using a vacuum applicator with an accessory insert.

Official Title
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CoolSculpting the Abdomen Using an Applicator With a Crown Cooling Insert

Conditions
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Body Fat Disorder

Intervention / Treatment
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* Device: CoolSculpting Treatment


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 on the abdomen, which in the investigator's opinion, may benefit from the treatment. Subject is a candidate for a standard CoolSculpting treatment with a CoolMax applicator. No 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 course of the study. Subject has read and signed the study written informed consent form. Exclusion Criteria Subject has had a surgical procedure(s) 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, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria. Subject has a known history of Raynaud'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 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 or any other metal containing implant. Subject is pregnant or intending to become pregnant during the study period (in the next 5 months). Subject is lactating or has been lactating in the past 6 months. Subject has a history of hernia in the areas to be treated. 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. Subject is prone to severe claustrophobia (during MRI scans). 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CoolSculpting Treatment Cohort A<br>Cohort A will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 60 minutes using the CoolMax applicator without the Crown Cooling Insert. The contralateral side (Abdominal side 2) will be treated with the Crown Cooling Insert at a second protocol-defined temperature for 45 minutes. Each half of the abdominal area will be treated once, for a total of two treatments per subject. | Device: CoolSculpting Treatment<br>* The CoolSculpting device will be used to perform treatments.<br>|
| Active Comparator: CoolSculpting Treatment Cohort B<br>Cohort B will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 45 minutes using the CoolMax applicator with the Crown Cooling Insert. The contralateral side (Abdominal side 2) will be treated with a second protocol-defined temperature for 60 minutes with the Crown Cooling Insert. Each half of the abdominal area will be treated once, for a total of two treatments per subject. | Device: CoolSculpting Treatment<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 |
| --- | --- | --- |
| Percentage of Accurately 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 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. Success is defined as at least 70% correct identification of pre-treatment images by two out of three reviewers. | 12 weeks post treatment | 
| Participants With Unanticipated Adverse Device Effects (UADE) | The number of unanticipated device effects will be tabulated to assess safety of the device and applicator accessory (Crown Cooling Insert). Adverse event data is collected from the time of enrollment through the 12 week follow-up visit. | Enrollment through 12 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction Questionnaire | Subject satisfaction with the treatment experience data will also be collected via a written questionnaire at the 12-week follow up visits. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be: 1) very satisfied; 2) somewhat satisfied; 3) neither satisfied nor unsatisfied; 4) somewhat unsatisfied; 5) very unsatisfied. | 12 weeks post-final treatment |