The efficacy and safety study of JCS-01 non-invasive focused ultrasound fat reduction machine / 中国医疗器械杂志

ABSTRACT

<p><b>OBJECTIVE</b>To evaluate the safety and efficacy of using the JCS-01 focused ultrasound fat reduction machine for noninvasively breaking fat cells and abdomen sculpting treatment.</p><p><b>METHOD</b>40 qualified subjects were enrolled in the study per the IRB-approved protocol and randomly assigned into trial and control groups. The fat reduction treatments were performed using the JCS-01 focused ultrasound fat reduction machine made by Beijing 3H Medical Technology Co., Ltd. The trial group received ultrasound energy treatment in their abdominal subcutaneous adipose tissue on the 1st and 7th days of the trial. The control group followed the similar procedure except that the ultrasound energy was turned off during treatments. Both the trial and control groups were followed-up on 1,7,14, 35 days post treatment.</p><p><b>RESULTS</b>The waist circumference measured on 14, 35 days were reduced 2.52 cm +/- 1.04 cm and 3.31 cm +/- 0.67cm in comparison with the baseline values in the trial group, reaching the protocol hypothesis of at least 1.5 cm abdominal circumference reduction, which demonstrated the treatment efficacy. The adverse events included minor and transient thermal sensation and mild pain in the treated abdomen area in the trial group. No other adverse events were observed. Clinical biochemistry assay testing showed that the subjects liver and kidney function indicators had no significant change.</p><p><b>CONCLUSION</b>It is safe and effective to use the JCS-01 focused ultrasound fat reduction machine for abdomen fat reduction treatment.</p>