Clinical study to evaluate the performance of a noninvasive focused ultrasound device for thigh fat and circumference reduction compared to control.

Abstract

An FDA-cleared focused ultrasound device (UltraShape, Syneron Candela® , Yokneam, Israel) for noninvasive abdominal fat reduction produces localized mechanical cellular membrane disruption in adipocytes. This study seeks to determine the safety and efficacy of this device for use on the thighs. Fourteen women aged 33-60 were selected to receive 3 biweekly treatments to one thigh with the other thigh serving as an internal control. The subjects had a BMI range of 18-30kg/m2 and a weight range of 54-83kg. After the third treatment, patients were followed at 4, 8, and 16weeks. Fat thickness was measured by both caliper and ultrasound. In addition, thigh circumference and the patient's weight were measured. Pain, edema, erythema, and adverse events as well as investigator and patient overall satisfaction were recorded at all visits. In comparison with the control, there was a statistically significant average reduction in fat thickness measured by calipers at all time points with a 22.20% (P=.0165) improvement in 16weeks. By ultrasound, there was a 19.23% (4.03mm P=.0051) reduction in fat thickness at 16weeks with statistically significant improvement at the other follow-up visits. At 16weeks, thigh circumference improved, on average, 2.8cm (P=.0059) at the midline. 90.0% of the subjects were satisfied with the results at 16weeks, and the investigator was 100% satisfied. No adverse events were reported; no edema was observed in any subject. All subjects experienced mild erythema. All reported zero pain on a 0-10 scale. Focused ultrasound is safe, effective, and well tolerated to improve the circumference and fat thickness of the thighs without significant side effects. There were no significant adverse events. Investigators and subjects were highly satisfied with the results.