Non-Invasive Cooling of Fat Cells

This study has been completed.
Sponsor:
Information provided by:
Zeltiq Aesthetics
ClinicalTrials.gov Identifier:
NCT00762437
First received: September 27, 2008
Last updated: June 16, 2011
Last verified: May 2009
  Purpose

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 Intervention
Reduction of Unwanted Fat
Device: Zeltiq Dermal Cooling Device

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Zeltiq Aesthetics:

Primary Outcome Measures:
  • Visible improvement in treated area [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject satisfaction [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: January 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: Zeltiq Dermal Cooling Device
Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762437

Locations
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
  More Information

No publications provided

Responsible Party: John Allison, VP Research, Development & Clinical Affairs, Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT00762437     History of Changes
Other Study ID Numbers: ZA07005
Study First Received: September 27, 2008
Last Updated: June 16, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 23, 2014