title: Randomized sham-controlled trial to evaluate the safety and effectiveness of a high-intensity focused ultrasound device for noninvasive body sculpting.
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/cm (141 J/cm total), 59 J/cm (177 J/cm), or 0 J/cm (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/cm (-2.44; p = 0.01) but not the 47-J/cm treatment group (-2.06 cm; p = 0.13). In a per-protocol population, statistical significance versus sham was achieved for both the 59-J/cm (-2.52 cm; p = 0.002) and the 47-J/cm 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).
  
  
  METHODS
  Therapeutic, II.(Figure is included in full-text article.).
authors.affiliation: Eugene, Ore.; Mountlake Terrace, Wash.; Chapel Hill, N.C.; New Haven, Conn.; Chestnut Hill, Mass.; San Francisco, Calif.; New York, N.Y.; Hunt Valley, Md.; Scottsdale, Ariz.; and Omaha, Neb. From Oregon Health Science University; Cosmetic and Reconstructive Plastic Surgery; Aesthetic Solutions; The Savin Center; Skin Care Physicians; private practice; the Maryland Laser, Skin, and Vein Institute; Medicis Technologies Corporation; and the Advanced Skin Research Center.
authors.forename: Mark L
authors.initials: ML
authors.lastname: Jewell
authors.forename: Richard A
authors.initials: RA
authors.lastname: Baxter
authors.forename: Sue Ellen
authors.initials: SE
authors.lastname: Cox
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Donofrio
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Dover
authors.forename: Richard G
authors.initials: RG
authors.lastname: Glogau
authors.forename: Michael A
authors.initials: MA
authors.lastname: Kane
authors.forename: Robert A
authors.initials: RA
authors.lastname: Weiss
authors.forename: Patrick
authors.initials: P
authors.lastname: Martin
authors.forename: Joel
authors.initials: J
authors.lastname: Schlessinger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003357:Cosmetic Techniques; D005260:Female; D057086:High-Intensity Focused Ultrasound Ablation / Q000009:adverse effects / Q000295:instrumentation; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D055105:Waist Circumference; D055815:Young Adult