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Sponsored by: |
Zeltiq Aesthetics |
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Information provided by: | Zeltiq Aesthetics |
ClinicalTrials.gov Identifier: | NCT00762437 |
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 |
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Reduction of Unwanted Fat |
Device: Zeltiq Dermal Cooling Device |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Estimated Enrollment: | 240 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Device: Zeltiq Dermal Cooling Device
Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Zeltiq Aesthetics ( John Allison, VP Research, Development & Clinical Affairs ) |
Study ID Numbers: | ZA07005 |
Study First Received: | September 27, 2008 |
Last Updated: | June 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00762437 History of Changes |
Health Authority: | United States: Institutional Review Board |