Prospective, one arm, baseline-controlled clinical study for the evaluation of UltraShape contour I V3 for non-invasive fat reduction. The study will conduct using the UltraShape contour I V3 using U-Sculpt/VDF transducer on the abdomen.
This study is a prospective, one arm, up to four sites, clinical study showing the performance and safety of the UltraShape contour I V3 device non-invasive abdominal fat reduction for subjects with body mass index (BMI) above 28. Up to 60 healthy subjects will be enrolled. All subjects will undergo an assessment of their general health. During the treatment period, subject's fat thickness and circumferences will be measured and three successive UltraShape contour I V3 treatments will be performed (two weeks interval). Subjects will undergo treatment with the UltraShape contour I V3 using the U-Sculpt/VDF transducer on the abdomen area. Follow-up (FU) visits will be conducted as follows: 4 weeks FU, 8 weeks FU and 12 weeks FU post last treatment (Tx.3). Subject's fat thickness and circumference will be measured at each visit. Subject's blood test will be taken at baseline (prior to the first treatment, pre Tx.1), before the third treatment (pre Tx.3) and at 12 weeks follow-up visit (12wk FU). "No Pregnancy" will be verified before first treatment as well. In all following visits (TX2, Tx3 and FU 1 FU 2 and FU3), lack of pregnancy will be verified by questioning. Additionally, subject satisfaction and investigator satisfaction questionnaires will be completed at each FU visit. Finally, photography will be performed under visible light conditions of the front, right and left view. Optional, 3D photographs will be taken at each visit (at treatment visits, prior to treatments).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Tissue selectivity is achieved by a proprietary knowledge of parameters ensuring specific destruction of the fat cells only within the target area. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time
Sanctuary Plastic Surgery
Boca Raton, Florida, United States
833 Northern Boulevard
Great Neck, New York, United States
Laser and Skin Surgery Center
New York, New York, United States
Change in abdominal fat thickness compared to baseline
Abdominal fat thickness reduction post UltraShape contour I V3 treatments at 12 weeks follow-up (12wk FU) versus baseline.
Time frame: Baseline and 12 weeks
Change in abdominal fat thickness compared to baseline
Abdominal fat thickness reduction as measured by Ultrasound device post UltraShape contour I V3 treatments at follow-up visits
Time frame: Baseline, 8 weeks and 16 weeks
Change in abdominal fat thickness compared to baseline
Abdominal fat thickness reduction as measured by caliper post UltraShape contour I V3 treatments at follow-up visits versus baseline
Time frame: Baseline, 8 weeks, 12 weeks, and 16 weeks
Change in abdominal circumference reduction compared to baseline
Abdominal circumference reduction post UltraShape contour I V3 treatments at all treatment visits and follow-up visits
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Blood panel and fat lipid profile compared to baseline levels
Blood elements levels (e.g. lipids, Glucose) before the third treatment (at 4 weeks) and at the last follow-up visit (at 16 weeks) versus baseline
Time frame: Baseline, 4 weeks and 16 weeks
Investigator satisfaction
Investigator satisfaction: success is defined as when at least 50% of the observations are ranked as at least satisfied by the study investigator at each of the follow up visits
Time frame: 8 weeks, 12 weeks, and 16 weeks
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Subject satisfaction
Subject satisfaction: success is defined as when at least 50% of the subjects are satisfied with treatment results at each of the follow up visits
Time frame: 8 weeks, 12 weeks, and 16 weeks
Comfort level during treatment
Comfort assessment will be performed independently by subjects using a numerical scale. Subjects will assess treatment comfort immediately post each of the three treatments
Time frame: day 0, 2 weeks, and 4 weeks