Analysis of CoolSculpting by Zeltiq for Non-Invasive Cooling of Abdominal Fat Using the eZ App Large Applicator
Condition: Abdominal Fat; Adipose Tissue, Abdominal
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of single treatment vs.
      multiple treatments of CoolSculpting™ by Zeltiq™ Aesthetics for non-invasive cooling of
      subcutaneous fat using the eZ App 8 large applicator on the abdomen for fat layer reduction.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study population will consist of 20 subjects, ages 18-65 years, who have clearly
        visible fat in the lower abdomen and are appropriate candidates as per the Study Doctor's
        physical examination.
      
Keywords: Cryolipolysis; Abdominal Fat; Adipose Tissue; Fat Reduction; Non Invasive