Noninvasive body contouring by focused ultrasound: Safety and efficacy of the contour device in a multicenter, controlled, clinical study
Reference:Teitelbaum SA, Burns JL, Kubota J, et al. Plast Reconstr Surg. 2007 Sep;120(3):779-89.
Study Details:
- 164 healthy adults (137 subjects in the experimental group and 27 in the control, untreated group) at 5 sites
- 1 treatment to the abdomen, thighs, or flanks
- Circumference and fat thickness were measured at 12 weeks
- Circumference reduction was compared with the untreated group and with an untreated area (thigh) within the treated group
- Laboratory testing (including serum lipids), pulse oximetry, and liver ultrasound
Study Results:
- Mean reduction of 1.9 cm in treated area circumference (abdomen -2.3 cm, flanks -1.8 cm, thighs -1.6 cm)
- Mean reduction of 2.9 mm in skin fat thickness
- The majority of the effect was achieved within 2 weeks and was sustained at 12 weeks
- Within the control group, no statistical differences in the mean circumference reduction from baseline
- No clinically significant changes in the measured laboratory parameters
- 7 adverse events were reported, all of which were anticipated, mild, and resolved within the study period