Pilot Study on The Flanks of Asian Patients
Pilot Study on The Flanks of Asian Patients
This study will evaluate CoolSculpting and the CoolCurve applicator for non-invasive fat
 reduction in the flanks with sharp body curvature.
The purpose of this study is to evaluate the performance of the CoolCurve+ applicator for
 non-invasive fat layer reduction in flanks for Asian patient population.
Inclusion Criteria

 1. Male or female subjects > 18 years of age.

 2. Subjects must be of Asian descent.

 3. Subject has clearly visible fat on the flanks, which in the investigator's opinion,
 may benefit from the treatment.

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

 5. Subject with body mass index (BMI) up to 25. BMI is defined as weight in pounds
 multiplied by 703 divided by the square of the height in inches.

 6. Subject with sharp flank curvature that fits well with the CoolCurve+ applicator.

 7. 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.

 8. Subject has read and signed a written informed consent form.

 Exclusion Criteria

 1. Subject has had a surgical procedure(s) in the area of intended treatment.

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

 3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the
 area of intended treatment within the past 6 months.

 4. 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.

 5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold
 hemoglobinuria.

 6. 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.

 7. 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.

 8. Subject is taking or has taken diet pills or supplements for weight loss within the
 past month.

 9. 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).

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

 11. Subject is pregnant or intending to become pregnant during the study period (in the
 next 4 months).

 12. Subject is lactating or has been lactating in the past 6 months.

 13. Subject is unable or unwilling to comply with the study requirements.

 14. Subject is currently enrolled in a clinical study of any other unapproved
 investigational drug or device.

 15. 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.