Abdominal Fat Clinical Trial
Official title:
Baseline Controlled Two-arm Multi-Center Study to Evaluate the Safety and Efficacy of Combined Multi-Focus Treatments of UltraShape® Contour I V3 System and VelaShape II Device for Non-Invasive Circumference Reduction
The purpose of this study is to compare the clinical performance of the Ultrashape system with VelaShape II device for reduction of the waist.
UltraShape® Contour I V3 system is a non-invasive (not breaking the skin) focused ultrasound
for body contouring purposesdesigned to selectively disrupt sub-dermal fat cells employing
focused ultrasound. 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.
VelaShape is a non-invasive device for Body Reshaping and Cellulite Treatment. VelaShape
combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies
with mechanical manipulation.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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