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Non-invasive Cooling of Subcutaneous Fat

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ClinicalTrials.gov Identifier: NCT00762307
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : January 6, 2012
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2007
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in the fat layer thickness [ Time Frame: 2 months, 6 months ]

Secondary Outcome Measures :
  1. Subject satisfaction [ Time Frame: 2 months, 6 months ]

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

Inclusion Criteria:

  1. Male or female subjects > 18 years of age.
  2. Subject has clearly visible fat on the flanks, thighs, abdomen, or back.
  3. Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month.
  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 is taking 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
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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 ClinicalTrials.gov identifier (NCT number): NCT00762307


Locations
United States, California
Investigational Site
Dublin, California, United States
Investigational Site
Fremont, California, United States
Investigational Site
Pleasanton, California, United States
Investigational Site
San Ramon, California, United States
Sponsors and Collaborators
Zeltiq Aesthetics
More Information
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Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT00762307     History of Changes
Other Study ID Numbers: JM07001
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 2012