China Clinical Trial for Therapeutic MR-HIFU 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||China Clinical Trial for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids|
- Change in fibroid volume [ Time Frame: At baseline and at 6 months after treatment ] [ Designated as safety issue: No ]Proportion of patients with treated fibroid volume at 6 months after treatment reduced to 90% or less of treated fibroid volume at baseline (before MR-HIFU treatment)
- Adverse Events [ Time Frame: Within 6 months after treatment ] [ Designated as safety issue: Yes ]Number of Adverse Events reported as resulting from MR-HIFU treatment
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: MR-HIFU Treatment
Patients in this arm will receive MR-HIFU uterine fibroid treatment
Device: MR-HIFU uterine fibroid treatment
A single treatment session for uterine fibroids with the MR-HIFU device.
Other Name: Philips Sonalleve MR-HIFU
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588899
|Peking University First Hospital|
|Beijing, Beijing, China|
|First Affiliated Hospital of Medical College of Xi'an Jiaotong University|
|Principal Investigator:||Qinping Liao||Peking University First Hospital|
|Principal Investigator:||Yueling Wang||First Affiliated Hospital Xi'an Jiaotong University|