| Object:to explore the safety and efficacy of fat reduction treated by non-invasive focused ultrasound.Methods:A randomized double-blind negative control clinical trial was carried out on the excess fat of40volunteers’ abdomen by a JCS-01non-invasive focused ultrasound device produced by Beijing Hui Fukang medical technique company. Treatments were conducted by the device on dayl and day7. During each treatment3times scans by non-invasive focused ultrasound were accomplished. On dayl,7(the moment after treatments) and day14,35we recorded follow-up data, including abdomen circumferences and imaging data. Observations on the area treated and inquiries on feeling were conducted during treatments. Before the first treatment and14days after it, laboratory examinations were tested, including liver function, blood lipid tests, etc.Results:36volunteers accomplished2sessions of treatments and all follow-up. Abdomen circumference of volunteers in the test group decreased of (1.03±0.38) cm,(0.65±0.53) cm each in twice treatments on average. On day14and35, our follow-up data showed that volunteers’abdomen circumference in the test group decreased of (2.52±1.04) cmã€(3.31±0.67) cm compared with their situation before treatments. They showed significant differences between the test group and the control group in statistics. During the process of treatments,4subjects in the experimental group complained about feeling of tepidity or pricking. One subject on blood test of triglyceride showed higher than her early normal result, which fell to the normal level at reexamination after7days.Conclusion:In the clinical trial in our department, it proves that it is safe and effective to be treated by non-invasive focused ultrasound body contouring device. |