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Plastic & Reconstructive Surgery:
doi: 10.1097/PRS.0b013e3182174278
Cosmetic: Original Articles

Randomized Sham-Controlled Trial to Evaluate the Safety and Effectiveness of a High-Intensity Focused Ultrasound Device for Noninvasive Body Sculpting

Jewell, Mark L. M.D.; Baxter, Richard A. M.D.; Cox, Sue Ellen M.D.; Donofrio, Lisa M. M.D.; Dover, Jeffrey S. M.D.; Glogau, Richard G. M.D.; Kane, Michael A. M.D.; Weiss, Robert A. M.D.; Martin, Patrick B.S.; Schlessinger, Joel M.D.

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Abstract

Background: High-intensity focused ultrasound presents a noninvasive approach to body sculpting for nonobese patients. The purpose of this study was to evaluate the safety and effectiveness of a high-intensity focused ultrasound device for sculpting of the abdomen and flanks.

Methods: Adults (aged 18 to 65 years) with subcutaneous abdominal fat greater than or equal to 2.5 cm thick who met screening criteria were randomized to receive high-intensity focused ultrasound treatment of the anterior abdomen and flanks at energy levels (a total of three passes each) of 47 J/cm2 (141 J/cm2 total), 59 J/cm2 (177 J/cm2), or 0 J/cm2 (no energy applied, sham control). The primary endpoint was change from baseline waist circumference at the iliac crest level at posttreatment week 12. Subjective aesthetic assessments included the Global Aesthetic Improvement Scale and a patient satisfaction questionnaire. Safety assessments included adverse events, laboratory values, and physical examinations.

Results: For the primary endpoint, in the intent-to-treat population, statistical significance versus sham was achieved for the 59-J/cm2 (–2.44; p = 0.01) but not the 47-J/cm2 treatment group (–2.06 cm; p = 0.13). In a per-protocol population, statistical significance versus sham was achieved for both the 59-J/cm2 (–2.52 cm; p = 0.002) and the 47-J/cm2 treatment groups (–2.10 cm; p = 0.04). Investigator subjective measures of global aesthetic improvement and patient satisfaction also favored each active treatment versus sham. Adverse events included mild to moderate discomfort, bruising, and edema. Laboratory values and physical examinations were unremarkable.

Conclusions: Treatment with this high-intensity focused ultrasound device reduced waist circumference and was generally well tolerated for noninvasive body sculpting. Reduction in waist circumference was statistically significant with both active treatments (per protocol).

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

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©2011American Society of Plastic Surgeons

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