A Randomized, Single‐Blind, Postmarketing Study of Multiple Energy Levels of High‐Intensity Focused Ultrasound for Noninvasive Body Sculpting

Background High‐intensity focused ultrasound (HIFU) is a nonsurgical, noninvasive body sculpting method. Objective To investigate preferences for treatment settings using a HIFU device. Materials and Methods HIFU was applied to the anterior abdomen in three passes of decreasing depth (1.6, 1.3, and 1.1 cm) in patients randomized to HIFU energy levels (each of 3 passes [total]) of 47 (141), 52 (156), or 59 (177) J/cm2. The primary assessment was week 12 post‐treatment change from baseline waist circumference at the level of the iliac crest for all treatment groups combined. Results The primary assessment achieved statistical significance (least squares mean 2.51 cm, 95% confidence interval [CI] = −3.14 to −1.88; p