Status:
COMPLETED
Non-invasive Cooling of Subcutaneous Fat
Lead Sponsor:
Zeltiq Aesthetics
Conditions:
Fat Disorder
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.
Detailed Description
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 using the Zeltiq Dermal Cooling device.
Eligibility Criteria
Inclusion
- Male or female subjects \> 18 years of age.
- Subject has clearly visible fat on the flanks, thighs, abdomen, or back.
- Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month.
- 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 is taking 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 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00762307
Start Date
January 1 2007
End Date
January 1 2012
Last Update
June 9 2021
Active Locations (4)
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1
Investigational Site
Dublin, California, United States
2
Investigational Site
Fremont, California, United States
3
Investigational Site
Pleasanton, California, United States
4
Investigational Site
San Ramon, California, United States