NCT01588899

China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids

China Clinical Trial for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Philips Healthcare · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DEVICE	MR-HIFU uterine fibroid treatment	A single treatment session for uterine fibroids with the MR-HIFU device.

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-12-01
• Completion: 2015-05-01
• First posted: 2012-05-01
• Last updated: 2015-10-22

Locations

2 sites across 1 country: China