Uterine Fibroids Clinical Trial
Official title:
For Research Purpose the Clinical Test of the Magnetic Resonance Imaging Guided Focused Ultrasound Ablation System on Uterine Fibroids
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)
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 to commercialize the self-developed MRgHIFU system. The mission is to conduct the
first-stage clinical test for 10 women with symptomatic uterine fibroids and to make two
sets of HIFU system. Meanwhile, the impact of quality of life and satisfaction with
treatment of the patients diagnosed with symptomatic uterine fibroids will be analyzed.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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