Non-invasive Cooling of Subcutaneous Fat

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics
ClinicalTrials.gov Identifier:
NCT00762307
First received: September 27, 2008
Last updated: January 4, 2012
Last verified: January 2012
  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:
  • Reduction in the fat layer thickness [ Time Frame: 2 months, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject satisfaction [ Time Frame: 2 months, 6 months ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: January 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (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 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
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: 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

No publications provided

Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT00762307     History of Changes
Other Study ID Numbers: JM07001
Study First Received: September 27, 2008
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 14, 2014