Clinical Test of the Magnetic Resonance Imaging Guided Focused Ultrasound Ablation System for Uterine Fibroids

Between 25 % - 50 % of women of childbearing age have uterine fibroids. Also, 25% of women with fibroids suffer from the metrorrhagia, menorrhagia, dysmenorrheal or pelvic compression so that they don’t have a good quality of life. The worse case is the fertility of patients with fibroids is hindered. The current clinical treatment is medication or surgery. Medication can only suppress the symptom temporarily when the hysterectomy method of removing part or all of uterus can cure the patient completely. However, the hysterectomy is an invasive operation and the women with fibroids who plan to have a baby don’t accept this kind of treatment. Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids has been developed and was approved by the US Food and Drug Administration (FDA) in 2004. The ultrasound waves emitted by the ultrasonic probe propagate through the skin, fat, muscle, soft tissues and converge on fibroids at focus. High energy/intensity at focus causes the thermal necrosis of the fibroid tissue in several seconds. The whole process of HIFU ablation of fibroids is monitored and guided by MR thermometery. The advantage of MR-HIFU modality includes no incision, outpatient treatment and few side effects. The objectives of this program are to verify the safety and effectiveness of the MRgHIFU system developed by the division of Medical Engineering of National Health Research Institutes (NHRI), to achieve the clinical trial at the Chang-Gung Memorial Hospitals of Linkou and Kaohsiung and to commercialize the self-developed MRgHIFU system. The project will be carried out for three years. In the first year, the tasks including mini-pig animal experiments, application for IRB and DOH clinical trial, tests of medical device safety and EMC, three sets of HIFU system will be performed. The mission of the second year is to conduct the first-stage clinical test for 20 women with symptomatic uterine fibroids and to make two sets of HIFU system. For the third-year project, the 2nd-stage clinical trial for 60 - 80 patients and additional HIFU systems for multisite will be accomplished.

Project ID:PC10002-0029
External Project ID:NSC100-2321-B182-002