Analysis of CoolSculpting by Zeltiq for Non-Invasive Cooling of Abdominal Fat Using the eZ App Large Applicator
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01318343|
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : March 31, 2015
|Condition or disease|
|Abdominal Fat Adipose Tissue, Abdominal|
The Zeltiq Cooling Device to be used in this study (i.e, CLN1) is designed to non-invasively cool skin and subcutaneous fat. The device provides cooling at a controlled preset level (i.e., temperature) as defined by a pre-programmed treatment profile and provides continuous feedback on the temperature of the cooling plate interface with the skin. The device also is able to provide warming at a controlled and variable, preset temperature.
The cooling device includes an applicator, which is the component used to apply cooling and warming to the treatment site, and the control unit which houses the system controller, power source, and other hardware. Each applicator is comprised of at least two thermoelectric coolers with an aluminum plate which is the primary skin interface for cooling and warming. The thermoelectric cooler is controlled and powered by a thermoelectric cooler controller is part of the control system. The device allows a well-controlled temperature to be applied to and maintained at the surface of the treatment area.
The Zeltiq Aesthetics Cooling Device to be used in this study has one applicator configuration. The vacuum applicator, which includes a small amount of vacuum pressure to create the massage effect. A disposable sleeve is provided for use with each of these applicators to provide an interface between the applicator and the skin. Sensors are included in the disposable sleeve to measure the temperature at the interface and to provide feedback to ensure appropriate control of the applicator temperature.
For the protection of the subject, safety features are incorporated into the device to avoid any unexpected excursions in the temperature. The device will automatically terminate the procedure if the measured temperature exceeds the minimum and maximum programmed temperature by more than one degree, i.e., 1ºC colder than the minimum programmed cooling temperature or 1ºC warmer than the maximum programmed temperature. Furthermore, the device has been tested extensively prior to being made available for use in this clinical study. Electrical safety tests to established standards (IEC-60601, UL-2601) have been performed and extensive testing has been performed to demonstrate device temperature reproducibility. Biocompatibility testing has been performed on any materials that are to contact the treatment site.
The study is intended to evaluate the large applicator of the Zeltiq Aesthetics non-invasive cooling device and to evaluate treatment of the lower abdomen to determine if non-invasive cold exposure will consistently result in a reduction of fat when used by clinicians in an environment that represents routine clinical practice.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Analysis of CoolSculpting by Zeltiq for Non-Invasive Cooling of Subcutaneous Fat of the Abdomen Using the eZ App Large Applicator|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||February 2012|
Treatment Group 1
Eight (8) subjects will receive one (1) treatment with the eZ8 Large Applicator.
Treatment Group 2
Eight (8) subjects will receive two (2) treatments two (2) months apart with the eZ8 Large Applicator.
Treatment Group 3
Four (4) subjects will receive one (1) treatment, six (6) months after the previous treatment with the eZ App 8 large applicator to the abdomen. This is the same applicator that is being evaluated in this study. These subjects have been treated on-site at the Laser & Skin Surgery Center of New York by the study doctor.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318343
|United States, New York|
|Laser & Skin Surgery Center of New York|
|New York, New York, United States, 10016|
|Principal Investigator:||Roy G Geronemus, MD||Laser & Skin Surgery Center of New York|