DualSculpting the Abdomen Using CoolSculpting

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and efficacy of abdominal DualSculpting with CoolAdvantage applicators.

Detailed Description
-----------------
The study will evaluate the safety and efficacy of non-invasive fat reduction in the abdomen using two applicators.

Official Title
-----------------
DualSculpting the Abdomen Using CoolSculpting

Conditions
-----------------
Body Fat Disorder

Intervention / Treatment
-----------------
* Device: The ZELTIQ System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Male or female subjects >22 years of age and < 65 years of age. Subject who has been assessed to be eligible to receive multiple DualSculpting treatments on the abdomen using the CoolAdvantage and/or CoolAdvantage Plus 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 treatmentSubject 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 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. 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
-----------------
Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zeltiq Dual Sculpting Treatment Group<br>All subjects treated with CoolSculpting System using the CoolAdvantage and CoolAdvantage Plus applicators simultaneously on the abdomen. | Device: The ZELTIQ System<br>* The CoolSculpting System will be used to perform the treatments with the CoolAdvantage family of applicators.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Correctly Identified Photos by Blinded Reviewers | 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. 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 primary efficacy endpoint of the study was the correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment images by two out of three blinded, independent reviewers. Success was defined as at least 70% correct identification of the baseline (pre-treatment) photographs. | Baseline to 12 weeks post-treatment | 
| Safety of the Zeltiq Device | The incidence of unanticipated adverse device effects will be measured. It is expected there will be zero UADEs. | 12 week post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction | Subject satisfaction with the Zeltiq procedure as determined by positive responses in a subject satisfaction questionnaire administered at the 12 weeks post-treatment visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses, with lower numbers (e.g. 1 or 2) indicating positive responses and higher numbers indicating less positive responses. | 12 weeks post-treatment |