CompletedNot Applicable

Non-Invasive Cooling of Fat Cells

United States175 participantsStarted 2008-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Percentage of Participants With Visible Improvement in Treated Area

Timeframe: 4 months

Trial details

NCT IDNCT00762437

SponsorZeltiq Aesthetics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-11-17

Results submitted2025-04-07

View on ClinicalTrials.gov More Reduction of Unwanted Fat trials