Prospective, one arm, baseline-controlled, clinical study for the evaluation of the UltraShape Power treatment using the U-Sculpt Power Transducer for non-invasive abdominal fat and circumference reduction.
Up to 120 healthy adult volunteers, seeking noninvasive abdominal fat and circumference reduction, male and females, 18 to 60 years of age from 6 investigational sites. Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) with the UltraShape Power device utilizing the U-Sculpt Power Transducer according to the study protocol. Subjects will return for 3 follow-up visits: four weeks (4wk FU), eight weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Third Treatment). Each subject will be enrolled for total expected study duration of 16 weeks. Subject's abdominal fat thickness and circumference will be measured at the measurements points and will be assessed at each visit. Additionally, a subject questionnaire will be completed in each follow-up visit (4wk, 8wk and 12wk FU). Finally, photography will be performed under visible light conditions of the front, right, left and back view. Most of the assessments will occur at each of the visits (all treatments and all follow-up visits) to the clinic.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Tissue selectivity is achieved by a proprietary knowledge of ultrasound 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
Laser Skin Surgery Center of Northern California
Sacramento, California, United States
Prana Medical Aesthetics
Jacksonville Beach, Florida, United States
Baumann Cosmetic and Research Institute, Inc
Miami, Florida, United States
DuPage Medical Group
Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound
Abdominal fat thickness change post UltraShape treatments at 12 weeks follow-up (12wk FU) after final treatment versus baseline
Time frame: Baseline and 16 weeks (4 weeks treatment + 12 week follow up)
Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound
Abdominal fat thickness change as measured by ultrasound post UltraShape Power treatments at 4-week, 8-week and 12-week (from baseline visit) versus baseline
Time frame: Baseline and at 4, 8, and 12 weeks (from baseline visit)
Change in Abdominal Circumference Compared to Baseline
Abdominal circumference change post UltraShape Power treatments
Time frame: Baseline and at 4, 8, 12 and 16 weeks (from baseline visit)
Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome
Satisfaction assessment will be performed independently by the investigator using a 4-point Likert scale questionnaire from 0 = dissatisfied to 3= very satisfied. The values in the data table reflect the number of Investigators who were "satisfied" or "very satisfied" (i.e., "reported a 2 or 3") with Participant Treatment Outcome, as assessed by the questionnaire.
Time frame: 8, 12 and 16 weeks (from baseline visit)
Number of Participants Reporting Satisfaction With Treatment Outcome
Satisfaction assessment will be performed independently by the subjects using a 4-point Likert scale questionnaire from 0 = dissatisfied to 3= very satisfied. The values in the data table reflect the number of participants who were "satisfied" or "very satisfied" (i.e., "reported a 2 or 3") with Treatment Outcome, as assessed by the questionnaire.
Time frame: 8, 12 and 16 weeks (from baseline visit)
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Naperville, Illinois, United States
A Womans Touch Plastic Surgery
Louisville, Kentucky, United States
Syneron Candela Institute for Education Clinic
Wayland, Massachusetts, United States
Union Square Laser Dermatology
New York, New York, United States
Jewell Plastic Surgery
Eugene, Oregon, United States
Pain Scale for Rating Discomfort Associated With Treatment
Comfort assessment will be performed independently by the subjects using a numerical scale (0-no discomfort to 10-Worst possible discomfort). The subjects will answer this questionnaire after each of the three treatments.
Time frame: Day 0 (1st treatment), at 2 weeks (2nd treatment) and at 4 weeks (3rd treatment)