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

Abstract

High-intensity focused ultrasound (HIFU) is a nonsurgical, noninvasive body sculpting method. To investigate preferences for treatment settings using a HIFU device. 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/cm(2). 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. The primary assessment achieved statistical significance (least squares mean 2.51 cm, 95% confidence interval [CI] = -3.14 to -1.88; p < .001), with no significant differences between groups. At week 12, 69% to 86% of patients and 73% to 79% of investigators rated appearance as improved or much improved. The average worst pain (100-mm visual analog scale) experienced during treatment was mild (47 J/cm(2): 17.1 mm, 95% CI = 4.33-29.81 mm; 52 J/cm(2): 24.6 mm, 95% CI = 12.24-36.95 mm; 59 J/cm(2): 30.9 mm, 95% CI = 18.71-43.17 mm). There were no serious adverse events. HIFU treatment at different energy levels and multiple tissue depths was well tolerated and effective in reducing waist circumference.