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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Reduction of Unwanted Fat Device: Zeltiq Dermal Cooling Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: 1 Device: Zeltiq Dermal Cooling Device
Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.

Primary Outcome Measures :
  1. Visible improvement in treated area [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Subject satisfaction [ Time Frame: 4 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00762437

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United States, California
Investigational Site
Sacramento, California, United States
Investigational Site
San Diego, California, United States
United States, District of Columbia
Investigational Site
Washington, District of Columbia, United States
United States, Florida
Investigational Site
Miami, Florida, United States
United States, Illinois
Investigational Site
Chicago, Illinois, United States
United States, Maryland
Investigational Site
Baltimore, Maryland, United States
United States, Massachusetts
Investigational Site
Boston, Massachusetts, United States
United States, Minnesota
Investigational Site
Minneapolis, Minnesota, United States
United States, New Jersey
Investigational Site
Hackensack, New Jersey, United States
United States, New York
Investigational Site
New York, New York, United States
United States, Texas
Investigational Site
Dallas, Texas, United States
Sponsors and Collaborators
Zeltiq Aesthetics
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Responsible Party: John Allison, VP Research, Development & Clinical Affairs, Zeltiq Aesthetics Identifier: NCT00762437    
Other Study ID Numbers: ZA07005
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: May 2009