CoolSculpting of the Distal Thigh Study

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a small area applicator for non-invasive subcutaneous fat reduction in the distal thigh.

Detailed Description
-----------------
This study will investigate the use of a Small Area Applicator with the CoolSculpting device for reducing subcutaneous fat in the distal thigh. The study will evaluate the safety and effectiveness of treatments.

Official Title
-----------------
CoolSculpting Treatment of the Distal Thigh

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 has clearly visible fat on the distal thigh, which in the investigator's opinion, may benefit from the treatment. Subject has not had weight change exceeding 10 pounds in the preceding month. Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine 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. 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, 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 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 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: Treatment with Small Area Applicator<br>Each enrolled subject was treated on a single thigh, in the distal region. | Device: The ZELTIQ System<br>* The CoolSculpting System with a Small Area Applicator will be used to deliver treatments.<br>* Other names: CoolSculpting System;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Device- or Procedure-related Adverse Events | The number of device- or procedure-related adverse events will be tabulated. Adverse event data are collected throughout the study period from the time of enrollment through the final follow-up visit. | Study enrollment through 12-week final follow-up visit, approximately 15 weeks | 
| 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. 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. Note: Due to the inconsistency of site photographic practices, the photos were not reasonably evaluable and therefore the independent phot review was not conducted. | 12 weeks post final treatment |