Noninvasive Body Contouring by Focused Ultrasound: Safety and Efficacy of the Contour I Device in a Multicenter, Controlled, Clinical Study
Steven A. Teitelbaum, M.D. John L. Burns, M.D. Junichiro Kubota, M.D. Hidenori Matsuda, M.D. Morkel J. Otto, M.B.Ch.B., M.Pharm.Med., M.Phil. Yukio Shirakabe, M.D. Yoshiro Suzuki, M.D. Spencer A. Brown, Ph.D.
Santa Monica, Calif.; Dallas, Texas,Tokyo, Japan; and London, United Kingdom
Background: The removal of unwanted body fat using a noninvasive technique is desirable to patients and physicians. The authors describe a controlled, multicenter, clinical trial assessing the safety and efficacy of a focused therapeutic ultrasound device for noninvasive body contouring. Methods: Eligible healthy adult subjects were enrolled to theexperimental group or the control group at five sites. The experimental group received one treatment with the Contour I device (UltraShape Ltd., Tel Aviv, Israel) in the abdomen, thighs, or flanks and were evaluated over a 12-week period. Efficacy outcomes were reduction of circumference and fat thickness. Circumference reduction was compared with the untreated group and with an untreated area (thigh)within the treated group. Safety monitoring included laboratory testing (including serum lipids), pulse oximetry, and liver ultrasound. Results: One hundred sixty-four subjects participated in the study (137 subjects in the experimental group and 27 in the control, untreated group). A single Contour I treatment was safe and well tolerated and produced a mean reduction of approximately 2 cm intreatment area circumference and approximately 2.9 mm in skin fat thickness. The majority of the effect was achieved within 2 weeks and was sustained at 12 weeks. No clinically significant changes in the measured safety parameters were recorded. Seven adverse events were reported, all of which were anticipated, mild, and resolved within the study period. Conclusion: The Contour I device provides a safeand effective noninvasive technology for body contouring. (Plast. Reconstr. Surg. 120: 779, 2007.)
ody contouring by liposuction is the most frequently performed cosmetic surgery procedure in the United States, with an estimated 455,000 cases in 2005.1 This number repreFrom the University of California, Los Angeles Medical Center; Dallas Plastic Surgery Institute; private practice; TokyoMedical University; and Department of Plastic Surgery and the Nancy L. & Perry Bass Advanced Wound Healing Laboratory, University of Texas Southwestern Medical Center. Received for publication September 19, 2006; accepted January 5, 2007. Presented at the 85th Annual Meeting of the British Association of Dermatologists, in Glasgow, Scotland, and the European Academy of Dermatology and Venereology,in Paris, France, July of 2005; the British Association of Aesthetic Plastic Surgeons, in London, United Kingdom, and American Society of Plastic Surgeons 2005, September of 2005; Plastic Surgery, in Paris, France, November of 2005; the International Master Course on Aging Skin, in Paris, France, January of 2006; the Israeli Dermatology Meeting, in Tiberius, Israel, June of 2006; the 14thInternational Anti-Aging Congress and the International Master Course on Aging Skin, in Paris, France, July of 2006; and the International Society for Therapeutic Ultrasound, in Oxford, United Kingdom, August of 2006. Copyright ©2007 by the American Society of Plastic Surgeons DOI: 10.1097/01.prs.0000270840.98133.c8
sents less than 1 percent of the potential pool: 45 million Americans diet every yearto improve health and enhance body contour, and even this is a small portion of the 130 million Americans who are overweight.2,3 Liposuction methodology has evolved over several decades to yield a procedure that is safer and amenable to regional anesthesia or conscious sedation and can be performed in an outpatient setting.4 –7 Despite the many advances in liposuction technique, it retains risk...