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Clinical Papers

Noninvasive Body Contouring by Focused Ultrasound: Safety and Efficacy of the Contour I 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