Safety and efficacy of ultrashape contour i treatments to improve the appearance of body contours: Multiple treatments in shorter intervals

Abstract

Background: The UltraShape Contour I System (CE 0344; UltraShape Ltd., Yoqneam, Israel) is a noninvasive fat reduction and body contouring system currently approved for use outside the United States that utilizes focused ultrasound to selectively disrupt adipocytes. Objective: To evaluate the clinical safety and efficacy of the Contour I system when the intervals between treatments are shortened. Methods: Twenty-five healthy Caucasian women were selected from the patient population at two clinics in Paris, France, and received three 30- to 90-minute Contour I treatments in the abdominal region at two-week intervals. Safety parameters evaluated included adverse events, local skin reaction, and pain. Efficacy parameters evaluated included treatment area circumference, body weight, and comparison of before and after photos. Untreated thigh areas served as an internal control. Subjects were followed for 84 days after the last treatment (day 112). Results: No adverse events occurred. The majority of subjects (n = 23; ∼90%) reported no pain. Mean midline circumference (2 cm below midline) was reduced by 2.47 cm (P