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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
UltraShape Power is a non-invasive focused ultrasound device, approved by the FDA (160896K;170370K); CE; Israeli Ministry of Health. The UltraShape Power system works by emitting acoustic waves of focused ultrasonic energy (200 ± 30 KHz frequency) that converge into a confined focal volume underneath the skin, thereby, targeting only subcutaneous fat at a controlled depth. Unlike traditional ultrasound technology, UltraShape Power's energy transmits pulsed ultrasound, allowing control over temperature elevation. The system comprised of two main parts: * The Main console * Transducer
The Baruch Padeh Medical Center
Tiberias, Israel
Fat Volume reduction
MRI measurements for fat thickness in cc (cubic centimeter)
Time frame: 12 weeks follow-up (12wk FU) versus baseline
Treatment Safety as Assessed by Blood Lipid Level
Verification similar of post-treatment and pre-treatment (baseline) blood lipid levels values \[%\]
Time frame: up to 24 weeks
MRI Measurement of Fat Thickness Reduction
MRI measurements for Fat thickness in mm
Time frame: 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.
Ultrasound Measurement of Fat Thickness Reduction
Ultrasound measurements for Fat thickness in mm
Time frame: 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.
Fat Volume reduction
MRI measurements for fat thickness in cc (cubic centimeter)
Time frame: 4 weeks, 8 weeks and (optional) 24 weeks versus baseline.
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