China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids
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|ClinicalTrials.gov Identifier: NCT01588899|
Recruitment Status : Completed
First Posted : May 1, 2012
Last Update Posted : October 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Uterine Fibroids||Device: MR-HIFU uterine fibroid treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||China Clinical Trial for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||May 2015|
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
- Change in fibroid volume [ Time Frame: At baseline and at 6 months after treatment ]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 ]Number of Adverse Events reported as resulting from MR-HIFU treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|