Status:
COMPLETED
Non-Invasive Cooling of Fat Cells
Lead Sponsor:
Zeltiq Aesthetics
Conditions:
Reduction of Unwanted Fat
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Male or female subjects \> 18 years of age.
- 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.
- 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.
- Subject has read and signed a written informed consent form.
Exclusion
- Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.
- Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.
- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Subject has used diet pills within the past 6 months.
- Subject is unable or unwilling to comply with the study requirements.
- Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Patient is pregnant or intending to become pregnant in the next 9 months.
- Patient is lactating or has been lactating in the past 9 months.
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2009
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00762437
Start Date
January 1 2008
End Date
December 18 2009
Last Update
May 25 2025
Active Locations (11)
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1
Investigational Site
Sacramento, California, United States
2
Investigational Site
San Diego, California, United States
3
Investigational Site
Washington D.C., District of Columbia, United States
4
Investigational Site
Miami, Florida, United States