A Pilot Study Testing a Noninvasive Cryolipolysis Device Versus a High Intensity Focused Ultrasound Device for Fat Reduction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of the Zeltiq System and LipoSonix System for fat reduction and improving body shape.

Detailed Description
-----------------
At baseline visit, subjects who meet inclusion and exclusion criteria will be enrolled. Subjects will be randomly assigned to receive Zeltiq treatment to either their right or left flank The contralateral flank will receive Liposonix treatment. A total of three identical treatments will be completed monthly for 3 consecutive months. Subjects will return 4 weeks following the last treatment for follow up photography, measurements, and assessments. This study is a pilot study designed to determine feasibility of these procedures.

Official Title
-----------------
Pilot Study Comparing the Effectiveness of a Noninvasive Cryolipolysis Device vs. a High Intensity Focused Ultrasound Device for Fat Reduction: A Randomized Control Trial

Conditions
-----------------
Abdominal Fat

Intervention / Treatment
-----------------
* Device: High Intensity Focused Ultrasound Device
* Device: Noninvasive Cryolipolysis Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects ages 30-65 years old. Body mass index (BMI) between 18 and 29.99. (BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches). Subjects are in good health. Willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation. Subjects agree to maintain their weight (i.e. within 5 pounds) by not making any changes to diet or lifestyle during the study. The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator. Exclusion Criteria: Pregnant or lactating or intends to become pregnant in the next 9 months. Unable to understand the protocol or to give informed consent. Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area. Pending and/or anticipated major change in diet or exercise pattern in the six weeks following the last treatment or who has taken diet pills within the last 6 months.. History of asthma or chronic obstructive pulmonary diseases. Active skin disease or skin infection in the treatment area. Bleeding tendency or coagulopathy. Subjects who are allergic to lidocaine. Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Noninvasive Cryolipolysis Device<br>The Zeltiq System is a noninvasive (not breaking the skin) device that reduces fat by freezing fat cells until they break apart. | Device: Noninvasive Cryolipolysis Device<br> <br> * Other names: Zeltiq;|
| Active Comparator: High Intensity Focused Ultrasound Device<br>The LipoSonix System is a noninvasive ultrasound device, which can be used to selectively target and destroy fat tissue located deep under the skin. | Device: High Intensity Focused Ultrasound Device<br> <br> * Other names: Liposonix;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 12 | The primary outcome was a blinded rating of the treatment area (Noninvasive Cryolipolysis Device vs. a High Intensity Focused Ultrasound Device) with the best cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 12). | 1 hour at baseline and week 12 |