UltraShape Power Device for Fat Reduction in Flanks
UltraShape Power Device for Fat Reduction in Flanks
Prospective, baseline-controlled evaluation of the UltraShape Power device for non-invasive
 fat reduction in flanks.
Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) with the UltraShape
 Power device according to the study protocol.

 One random flank will be treated with one pass or remained as a control (no treatment) while
 the second flank will be treated with multiple passes.

 Subjects will return for up to 4 follow up visits: 4 weeks, 8 weeks, 12 weeks and (optional)
 24 weeks following end of treatment/s.

 Each subject will be enrolled for total expected study duration of up to 28 weeks.

 After last follow up visit, subjects who wish will receive compensation treatments (up to 3)
 on the flank who received regular treatment (single pass) or remained as a control (no
 treatment).
Inclusion Criteria:

 1. Signed informed consent to participate in the study.

 2. Female and male subjects, 18 and 65 years of age at the time of enrolment

 3. Fitzpatrick Skin Type I to VI.

 4. Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).

 5. BMI interval: 19 ≤ BMI ≤ 30 (normal to overweight, but not obese).

 6. If female, not pregnant, lactating and must be either post-menopausal, surgically
 sterilized, or using a medically acceptable form of birth control at least 3 months
 prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods
 with spermicide or abstinence).

 7. In addition, negative pregnancy inquiry as reviewed before each treatment and each
 follow up visit for women with bearing potential (e.g. not menopause).

 8. General good health confirmed by medical history and skin examination of the treated
 area.

 9. Willing to follow the treatment and follow-up schedule and post-treatment care
 instructions.

 10. Willingness to refrain from a change in diet/ exercise/medication regimen for the
 entire course of the study.

 11. Willing to have photographs and images taken of the treated areas to be used
 de-identified in evaluations, publications and presentations.

 Exclusion Criteria:

 1. History of hypertension, ischemic heart disease, valvular heart disease, congestive
 heart failure, pacemaker/defibrillator, abdominal aortic aneurism

 2. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive
 status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue
 disease

 3. Having or undergoing any form of treatment for active cancer, or having a history of
 skin cancer or any other cancer in the areas to be treated, including presence of
 malignant or pre-malignant pigmented lesions

 4. Having any active electrical implant anywhere in the body, such as a pacemaker or an
 internal defibrillator

 5. Having a permanent implant in the treated area, such as metal plates or an injected
 chemical substance such as silicone

 6. Having undergone any other surgery in the treated areas within 3 months of treatment
 or during the study, including liposuction

 7. Previous body contouring procedures in the treatment area within 12 months

 8. History of skin disease in the treatment area, known tendency to form keloids or poor
 wound healing

 9. Suffering from significant skin conditions in the treated areas or inflammatory skin
 conditions, including, but not limited to, open lacerations or abrasions and active
 cold sores prior to treatment (duration of resolution as per the Investigator's
 discretion) or during the treatment course

 10. Skin lesions in the treatment area other than simple nevi on physical examination
 (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment
 area

 11. Very poor skin quality (i.e., severe laxity)

 12. Abdominal wall diastasis or hernia on physical examination

 13. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count
 within the last 3 months

 14. Obesity (BMI > 30)

 15. Childbirth within the last 12 months or breastfeeding women. Any acute or chronic
 condition which, in the opinion of the investigator, could interfere with the conduct
 of the study

 16. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six
 months)

 17. Inability to comply with fat measurement procedures (e.g., inability to hold breath
 for few seconds).

 18. Fat thickness lower than 1.5 cm before strapping at the treated area.

 19. Participation in another clinical study involving same anatomical areas within the
 last 6 months (or 30 days in case different anatomical areas were treated in previous
 trial/s).

 20. As per the Investigator's discretion, any physical or mental condition which might
 make it unsafe for the subject to participate in this study.