9/10/07
Clinical trial results using the UltraShape(TM) Contour I, a noninvasive ultrasound solution for body contouring, are published in the September issue of Plastic and Reconstructive Surgery.
The study, called "Body Contouring by Noninvasive Transdermal Focused Ultrasound: Safety and Efficacy of the Contour I Device in a Multi-center, Controlled, Clinical Study" demonstrates measurable and durable body circumference and fat thickness reduction after a single UltraShape treatment.
"With UltraShape finally there is a nearly painless, noninvasive, no downtime body contouring option that gives durable results," says Steven Teitelbaum, MD, lead investigator for UltraShape’s multi-center controlled clinical trial, and assistant clinical professor of plastic surgery at the David Geffen School of Medicine at the University of California, Los Angeles. "The system precisely delivers focused ultrasound energy strong enough to destroy fat cells but leave neighboring tissue unharmed."
The clinical trial was conducted in five centers—two in the US, one in the UK, and two in Japan—and included 164 healthy patients. Of those patients, 137 were treated with a single treatment and 27 were untreated (control group).
The study included treatment of the abdomen, flanks, and thighs. The study demonstrated a mean circumference reduction of 2 cm after a single treatment of localized fat deposits. No statistically significant weight loss was observed during the 84-day follow-up period. Therefore, the reduction in circumference was attributed to the treatment—not to weight loss. No clinically significant elevation of serum lipid profiles or changes in blood and urine tests were seen. Liver ultrasound was performed before and after treatment. There were no treatment induced changes to the liver. No serious adverse events were observed.
[www.medicalnewstoday.com, September 7, 2007]
