A novel nonfocused pulsed ultrasound technology for noninvasive circumference reduction.

There is a continuously growing demand for circumference reduction and body shaping technologies, with an overwhelming preference for non-invasive, pain-free procedures. This paper presents a novel body contouring device which uses pulsed, vacuum-assisted non-focused ultrasound. To evaluate the clinical safety and efficacy of the vacuum-assisted acoustic wave technology for circumference reduction of the abdominal region. Eighteen healthy women with a body mass index under 25 underwent four 20-min fat reduction treatments in the abdominal region, at 1-week intervals. Efficacy was evaluated by the change in abdominal circumference up to 12 weeks post treatment relative to baseline and by comparison of before and after photos by two blinded evaluators. Subjects rated their satisfaction with the treatment procedure and outcomes. Safety was evaluated by adverse events, local skin reaction, and pain assessments. 1 week after the final session, the mean reductions in abdominal circumference measured 5.4 ± 2.6 cm. At 1 month after the last session, the cumulative reduction in circumference was 5.8 ± 3.2 cm. Measurements take at 3 months after the last treatment showed abdominal circumferences decrease of an average 5.2 ± 3.1 cm relative to baseline measures. All patients reported a painless procedure and there were no treatment-induced severe adverse events. Most patients reported a positive change in body contour, with all subjects saying they would highly recommend the treatment to others. Assessments performed by blinded evaluators ranked six cases as very to extremely improved and an additional seven cases as somewhat improved. No dramatic weight fluctuations were recorded. This study demonstrates that a four-treatment course with an acoustic wave ultrasound applicator with 1-week intervals, leads to a significant reduction in abdominal circumference, lasting up to at least 3 months with no pain or side effects reported.