CompletedNot Applicable

Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction

United States19 participantsStarted 2012-11

Plain-language summary

Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the outcome of non-invasive fat reduction using the ZELTIQ System.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male or female subjects \> 18 years of age and \< 65 years of age.
✓. Subject has clearly visible fat on intended treatment area, which in the investigator's opinion, may benefit from the treatment(s).
✓. Subject has not had weight change exceeding 10 pounds in the preceding month.
✓. Subject with body mass index (BMI) less than 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
✓. Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
✓. Subject has read and signed a written informed consent form.

Exclusion criteria

✕. Subject presents a significant asymmetry of intended treatment areas.
✕. Subject has had a surgical procedure(s) in the area of intended treatment in the past 5 years.
✕. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment in the past 5 years.
✕. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
✕. Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
✕. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
✕. Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
✕. Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.

What they're measuring

Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel

Timeframe: Baseline, Week 16

Trial details

NCT IDNCT01728857

SponsorZeltiq Aesthetics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-03-10

Results submitted2025-02-17

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