Randomized Controlled Trial of Uterine Artery Embolization (UAE) Versus High-Intensity-Focused-Ultrasound (HIFU) for Treatment of Patients With Uterine Fibroids
The usual management for symptomatic uterine fibroid is surgery (myomectomy or
hysterectomy), in the current study, uterine artery embolization (UAE) is a form of
non-surgical and minimally invasive treatment, High-Intensity-Focused-Ultrasound (HIFU) is a
form of non-invasive treatment that can be completed as an out-patient within hours.
Embolization causes ischaemia and shrinkage of the fibroid and therefore symptomatic
relieve. HIFU is a medical technology that has been used for cancer treatment. Energy is
delivered from outside the body in a non-invasive manner to produce heat energy that causes
necrosis and shrinkage of the uterine fibroid thereby relieves the symptoms due to the
fibroid. It does not involve radiation. The clinical effectiveness of HIFU for uterine
fibroid is unknown, however, based on the knowledge of the clinical effectiveness of HIFU on
liver cancer and pancreatic cancer, there is reasonable ground to believe that HIFU is
effective for uterine fibroid.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment success rate
Technical success of treatment procedure and absence of symptoms of fibroid
6 months
No
Simon CH Yu, MD, FRCR
Principal Investigator
Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
VIR-13-02
NCT01834703
May 2009
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