Non-invasive Cooling of Subcutaneous Fat

Completed · Not applicable

Conditions studied: Fat Disorder

In brief

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.

Key facts

Study ID

NCT00762307

Run by

Zeltiq Aesthetics

People needed

60

Starts

2007-01-01

Expected to finish

2012-01-01

Last updated by the study team

2021-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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