Analysis of CoolSculpting by Zeltiq for Non-Invasive Cooling of Abdominal Fat Using the eZ App Large Applicator

Completed

Conditions studied: Abdominal Fat, Adipose Tissue, Abdominal

In brief

The purpose of this study is to evaluate the safety and efficacy of single treatment vs. multiple treatments of CoolSculpting™ by Zeltiq™ Aesthetics for non-invasive cooling of subcutaneous fat using the eZ App 8 large applicator on the abdomen for fat layer reduction.

Key facts

Study ID

NCT01318343

Run by

Laser and Skin Surgery Center of New York

People needed

20

Starts

2011-03-01

Expected to finish

2012-02-01

Last updated by the study team

2015-03-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female between the ages of 18 and 65 years of age.
• Clearly visible fat on an area of the lower abdomen appropriate for treatment with the non-invasive Zeltiq cooling device.
• Not had weight change fluctuations exceeding 5 pounds in the preceding 6 months.
• Read and sign a written informed consent form.

You may not qualify if…

• Had liposuction, or another surgical procedure(s) or mesotherapy (injections of minute natural extracts, drugs and other agents into the skin to eliminate fat deposits in cellulite) in area of intended treatment within the past 2 years.
• Had treatment with a cooling device within the past 6 months. (This exclusion does not apply to those enrolled in Group 3).
• Known history of injections into the abdomen (e.g., cortisone) within the past 6 months.
• Known history of cryoglobulinemia (abnormal blood proteins that thicken in cold temperatures), cold urticaria (large, allergic hives that occur when the skin is exposed to cold), or paroxysmal cold hemoglobinuria (sudden development of red blood cell breakdown causing hemoglobin [protein compound in blood] in the urine).
• Used diet pills within the past 6 months.
• Taking amino- or theophylline for asthma.
• You are unable or unwilling to comply with the study requirements.
• Any dermatological conditions or scars within the location of the treatment site that may interfere with the treatment or evaluation.
• Currently enrolled in a clinical study of any other unapproved investigational drug or device.
• Pregnant or intending to become pregnant in the next 9 months.
• Breastfeeding or have been breastfeeding in the past 9 months.
• Any other condition that would, in the professional opinion of the study doctor, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

Where it is running

• Laser & Skin Surgery Center of New York — New York, New York, United States

Full record on ClinicalTrials.gov

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