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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Device: MR-HIFU uterine fibroid treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women, age between 18 and 55 years Weight < 140 kg Pre- or peri-menopausal Uterine size < 24 weeks Cervical cell assessment by Pap smear/Thin-prep Cytologic Test (TCT): Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue Fibroids selected for treatment meeting the following criteria: Total planned ablation volume of all fibroids should not exceed 250 ml, and No more than 5 fibroids should be planned for ablation, and Dominant fibroid (diameter) is greater than or equal to 3 cm, and Fibroids which are completely non-enhancing under Magnetic Resonance (MR) contrast agent should not be treated as the identification of treated volume becomes ambiguous Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU protocol) fibroids should not be treated MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated Willing and able to attend all study visits Exclusion Criteria: Other pelvic disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis) Desire for future pregnancy Significant systemic disease, even if controlled Positive pregnancy test Hematocrit < 25% Extensive scarring along anterior lower abdominal wall (> 50% of area) Surgical clips in the direct path of the HIFU beam MRI contraindicated MRI contrast agent contraindicated Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible) Calcifications around or throughout uterine tissues Communication barrier Suspected malignancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR-HIFU Treatment<br>Patients in this arm will receive MR-HIFU uterine fibroid treatment | Device: MR-HIFU uterine fibroid treatment<br>* A single treatment session for uterine fibroids with the MR-HIFU device.<br>* Other names: Philips Sonalleve MR-HIFU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fibroid volume | 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) | At baseline and at 6 months after treatment | 
| Adverse Events | Number of Adverse Events reported as resulting from MR-HIFU treatment | Within 6 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibroids, Uterine Leiomyomas, HIFU, Ablation, High Intensity Focused Ultrasound