Non-Invasive Cooling of Fat Cells

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. Identifier: NCT00762437
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : June 20, 2011
Information provided by:
Zeltiq Aesthetics

September 27, 2008
September 30, 2008
June 20, 2011
January 2008
June 2011   (Final data collection date for primary outcome measure)
Visible improvement in treated area [ Time Frame: 4 months ]
Visible improvement in treated area based on photographic assessment of treated area versus the untreated control [ Time Frame: 4 months ]
Complete list of historical versions of study NCT00762437 on Archive Site
Subject satisfaction [ Time Frame: 4 months ]
Subject satisfaction as determined by completion of a questionnaire [ Time Frame: 4 months ]
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Non-Invasive Cooling of Fat Cells
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The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.
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Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Reduction of Unwanted Fat
Device: Zeltiq Dermal Cooling Device
Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Experimental: 1
Intervention: Device: Zeltiq Dermal Cooling Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female subjects > 18 years of age.
  2. Subject has clearly visible fat on an area of the body appropriate for treatment with the non-invasive Zeltiq cooling device such as the flanks, thighs, abdomen or back.
  3. Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month and plans to maintain their weight to within ±10 pounds over the next 6 months.
  4. Subject has read and signed a written informed consent form.

Exclusion Criteria:

  1. Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.
  2. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.
  3. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
  4. Subject has used diet pills within the past 6 months.
  5. Subject is unable or unwilling to comply with the study requirements.
  6. Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
  7. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
  8. Patient is pregnant or intending to become pregnant in the next 9 months.
  9. Patient is lactating or has been lactating in the past 9 months.
  10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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John Allison, VP Research, Development & Clinical Affairs, Zeltiq Aesthetics
Zeltiq Aesthetics
Not Provided
Not Provided
Zeltiq Aesthetics
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP