Non-Invasive Reduction of Abdominal Fat

Completed · Not applicable

Conditions studied: Fat Reduction

In brief

This study is being performed to reduce unwanted abdominal fat using a new applicator for the Zeltiq System.

Key facts

Study ID

NCT01101997

Run by

Zeltiq Aesthetics

People needed

60

Starts

2010-03-30

Expected to finish

2010-12-08

Last updated by the study team

2020-12-21

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 abdomen.
• Subject has not had weight change exceeding 10 pounds in the preceding month.
• Subject agrees to maintain their 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.

You may not qualify if…

• Subject has had a surgical procedure(s) in the area of intended treatment in the past 6 months.
• Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
• Subject has had a non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
• Subject 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 Reynaud'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.
• Subject body mass index (BMI) exceeds 40. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
• Subject is taking or has taken diet pills or supplements within the past month.
• Subject has any dermatological conditions or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
• Subject is pregnant or intending to become pregnant in the next 6 months.
• Subject is lactating or has been lactating in the past 6 months.
• Subject is unable or unwilling to comply with the study requirements.
• Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
• Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Where it is running

• Laser and Skin Surgery of Northern California — Sacramento, California, United States
• Flor Mayoral, M.D. — Coral Gables, Florida, United States
• Maryland Laser, Skin and Vein Institute — Hunt Valley, Maryland, United States
• Skin Care Physicians of Chestnut Hill — Chestnut Hill, Massachusetts, United States
• Zel Skin and Laser Specialist LLC — Edina, Minnesota, United States

Full record on ClinicalTrials.gov

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