High-intensity focused ultrasound for the reduction of subcutaneous adipose tissue using multiple treatment techniques.
BACKGROUND
High-intensity focused ultrasound (HIFU) is a noninvasive alternative to traditional invasive body sculpting procedures.


OBJECTIVE
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).


METHODS
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.


RESULTS
In the intent-to-treat (ITT) population, all subjects had a statistically significant mean circumferential reduction of -2.3 ± 2.9 cm (p < .0001) from baseline at 12 weeks, with no significant differences among the 5 treatment groups (ITT: p = .153). Analysis of secondary end points in the ITT population demonstrated a significant circumferential reduction starting as early as 4 weeks in all subjects (-1.1 ± 1.9 cm, p < .0001). Most subjects in all treatment groups showed improvements at 12 weeks as rated by the investigators and subjects.


CONCLUSIONS
High-intensity focused ultrasound treatment using either a low or high fluence setting in a GR or SR method is effective for circumferential waist reduction, resulting in statistically significant CBWC in all treatment groups.
*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.
Deanne M
DM
Robinson
Michael S
MS
Kaminer
Leslie
L
Baumann
A Jay
AJ
Burns
Jeremy A
JA
Brauer
Mark
M
Jewell
Mark
M
Lupin
Vic A
VA
Narurkar
Steven K
SK
Struck
Jennifer
J
Hledik
Jeffrey S
JS
Dover
D034861:Abdominal Wall; D000293:Adolescent; D000328:Adult; D015992:Body Mass Index; D002170:Canada; D003357:Cosmetic Techniques; D005260:Female; D005500:Follow-Up Studies; D057086:High-Intensity Focused Ultrasound Ablation / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D050151:Subcutaneous Fat / Q000000981:diagnostic imaging*; D016896:Treatment Outcome; D014463:Ultrasonography; D014481:United States; D055105:Waist Circumference