*SkinCare Physicians, Chestnut Hill, Massachusetts; †Baumann Cosmetic & Research Institute, Miami Beach, Florida; ‡Dallas Plastic Surgery Institute, Dallas, Texas; §Laser & Skin Surgery Center of New York, New York, New York; ?Jewell Plastic Surgery Center, Eugene, Oregon; ¶Cosmedica Laser Centre, Victoria, British Columbia, Canada; #Bay Area Laser Institute, San Francisco, California; **Struck Plastic Surgery, Atherton, California; ††Solta Medical, Inc., Hayward, California.
High-intensity focused ultrasound (HIFU) is a noninvasive alternative to traditional invasive body sculpting procedures.
To assess the effectiveness and tolerability of HIFU treatment using high and low fluence settings with 2 treatment techniques, grid repeat (GR) and site repeat (SR).
Two multicenter studies were conducted. Subjects underwent 1 HIFU treatment with 1 of 5 treatment protocols (total fluence, 150-180 J/cm). Primary end point was change from baseline in waist circumference (CBWC) at 12 weeks. Secondary end points included CBWC at 4 and 8 weeks and investigator- and subject-assessed clinical improvement. Adverse events were monitored throughout the study.
In the intent-to-treat (ITT) population, all subjects had a statistically significant mean circumferential reduction of -2.3 ± 2.9 cm (p