Pilot Study of CoolTXT for Non-Invasive Fat Reduction
Pilot Study of CoolTXT for Non-Invasive Fat Reduction
This study is being performed to reduce unwanted fat, in various body areas, using a new
 applicator and control unit for Zeltiq.
The purpose of this study is to evaluate the safety and feasibility of a new product under
 development for non-invasive fat reduction. The new product delivers controlled cooling via a
 conformable surface applicator, rather than the existing vacuum applicator. A range of
 treatment parameters will be investigated. At the investigator's discretion, each treatment
 area may receive up to 3 treatments, spaced 2 - 8 weeks apart. The subjects will return for
 follow-up at 2 months and 4 months after final treatment. Therefore, the entire study period
 may last up to 8 months.
Inclusion Criteria

 -  Male or female subjects > 18 years of age and < 65 years of age.

 -  Subject has clearly visible fat on intended treatment area(s), which in the
 investigator's opinion, may benefit from the treatment(s). Treatment areas include:
 abdomen, saddlebag (outer aspect of upper thighs), upper arms and inner thighs.

 -  Subject has not had weight change exceeding 10 pounds in the preceding month.

 -  Subject with body mass index (BMI) between 25 and 35. 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 has had a surgical procedure(s) in the area of intended treatment.

 -  Subject has had an invasive fat reduction procedure (e.g., liposuction,
 abdominoplasty, mesotherapy) in the area of intended treatment.

 -  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.

 -  Subject is taking or has taken diet pills or supplements within the past month.

 -  Subject has any dermatological conditions, such as moderate to excessive skin laxity,
 or scars in the location of the treatment sites that may interfere with the treatment
 or evaluation (stretch marks is not an exclusion).

 -  Subject has an active implanted device such as a pacemaker, defibrillator, or drug
 delivery system

 -  Subject is pregnant or intending to become pregnant in the next 8months.

 -  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.