Uterine Fibroids Clinical Trial
Official title:
China Clinical Trial for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
The purpose of this study is to demonstrate safety and effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) for treatment of uterine fibroids in a Chinese population.
This study is to confirm the safety and effectiveness of Magnetic Resonance Imaging-guided
High Intensity Focused Ultrasound (MR-HIFU) in ablating uterine tissue associated with
symptomatic leiomyomas. The importance of this therapy is that it offers a non-invasive,
uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal
women.
MR-HIFU uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system
identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the
study is to show treatment safety and effectiveness of the Philips Sonalleve MR-HIFU device
for uterine fibroids marketing approval in the Chinese market. MR-HIFU will be performed in
100 patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging
endpoints will be evaluated in all study patients at baseline and at 6 months
post-treatment. All patients will be followed up for 12 months post-treatment for safety.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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