Combined Modality of Focused Ultrasound and Radio-Frequency for Non-Invasive Fat Disruption and Body Contouring – Results of a Single Treatment Session
Background: Combining treatment modalities for fat disruption and body shaping has been frequently performed to achieve a synergistic effect. These modalities are usually used with time intervals between treatments due to safety concerns. Focused Ultrasound (FUS) is a well known method to disrupt fat tissue. This technology has a high safety profile when using cavitation effect as opposed to a thermal effect. Our objective was to prove that treating with FUS technology and RF in one session is safe and can achieve meaningful results.
Material and Methods: 24 subjects were treated in the abdomen during a single session which included RF treatment (Reaction™, VIORA) immediately before and after a treatment with non-thermal focused ultrasound (Contour I, UltraShape®). Two ultrasound treatment protocols were used, each in 12 subjects. Subjects were evaluated at day 7, 14 and 28 after the day of treatment. Safety variables included adverse event collection for the whole study population and laboratory evaluation in 12 subjects. Primary efficacy variables included circumference measurements.
Results: At 28 days, combined ultrasound-RF treatment resulted in mean circumference reductions of 3.0cm – 3.4cm depending on the ultrasound protocol used. 93% of subjects experienced a circumference reduction greater than 1.5cm. Only one mild adverse event was reported and was attributed to operator misuse of the RF device. Lab tests were normal throughout the study.
Discussion and Conclusion: Using FUS combined with RF, in one treatment session to disrupt fat tissue for the purpose of body contouring, is safe, effective and well tolerated.