Objective To explore the safety of fat reduction treated by non invasive focused ultrasound.Methods A randomized double-blind and negative control clinical trial was carried out on the excess fat of 40 subjects' abdomen by a JCS-01 non-invasive focused ultrasound device.Subjects received treatments with the device on day 1 and day 7.Observations on the area treated and inquiries on feelings were conducted during treatments.Before the first treatment and 14 days after the treatment,laboratory examinations were performed,including liver function,blood lipid tests,etc.Results 40 subjects participated in the trial and 36 subjects (18 each in both treatment and control groups) accomplished 2 times of treatments,all followed-up and laboratory examinations.During the process of treatments,4 subjects in the experimental group complained about feelings of tepidity or pricking.One subject on blood test of triglyceride showed slightly higher than her early normal result,which fell to the normal level at reexamination.Conclusions Subjects treated by non-invasive focused ultrasound at the area of no more than 500 cm2 every time and at an interval of 6 days manifest little changes on the blood test results,with slightly local reactions but no complaints during follow-up.

OBJECTIVETo evaluate the safety and efficacy of using the JCS-01 focused ultrasound fat reduction machine for noninvasively breaking fat cells and abdomen sculpting treatment.

METHOD40 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.

RESULTSThe 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.

CONCLUSIONIt is safe and effective to use the JCS-01 focused ultrasound fat reduction machine for abdomen fat reduction treatment.

Adult ; Body Fat Distribution ; Cosmetic Techniques ; Female ; High-Intensity Focused Ultrasound Ablation ; adverse effects ; instrumentation ; methods ; Humans ; Male ; Treatment Outcome ; Waist Circumference