Fat Reduction in the Flanks Area vs. Control
Fat Reduction in the Flanks Area vs. Control
Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation the
 performance of the UltraShape treatment for non-invasive fat reduction by compare control and
 treated flanks.

 Study subjects will undergo UltraShape treatments on one randomized flank using the
 U-Sculpt/VDF Transducer. The second flank will not be treated (control). Both flanks (treated
 and control) will be compared to baseline, as well as, one to each other
This study is a prospective, baseline and blinded controlled, comparison, clinical study
 showing the performance and safety of the UltraShape treatment for non-invasive fat reduction
 at the flanks area comparing improvement observed in treated versus control flanks.

 Up to 60 Healthy subjects in up to 4 investigational sites will be enrolled in this study.
 All subjects will undergo an assessment of their general health. During the treatment period,
 subject's fat thickness will be measured on both flanks. Three successive bi-weekly (two
 weeks interval) UltraShape treatments will be performed on one randomized flank, while the
 second flank will not be treated and served as a control.

 The study subjects will undergo UltraShape treatments on one flank using the U-Sculpt /VDF
 Transducer, the treated flank will remain steady along the study and will be comparing to the
 baseline and to the controlled flank Three follow-up visits will be conducted as follows: 4
 weeks (4wk FU), 8 weeks (8wk FU) and 16 weeks (16wk FU) post last treatment (Tx.3).

 Subject's fat thickness will be measured on both flanks in the measurements points using
 caliper at each visit (at treatment visits, prior to treatment). Ultrasound measurements will
 be taken at each visit, except for the second treatment visit, on each flank. Investigator
 satisfaction will be assessed at all FU visits. In addition, subject questionnaires will be
 completed at each follow-up visit. Photographs of the front, right, left and back view of
 each flank will be performed under visible light conditions at each study visit.
Inclusion Criteria:

 1. Signed informed consent to participate in the study.

 2. Female and male subjects, between 18 to 60 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: BMI between 22 to 30 (normal to overweight, but not obese).

 6. If female, not pregnant or lactating, 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 urine pregnancy test as tested before each treatment and at the
 last follow-up visit for women with child-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. Known 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 12 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 or herpes 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 above 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. Fat thickness lower than 2.5 cm after strapping at the treated area.

 18. 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).

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