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

October 21, 2015 updated by: Philips Healthcare

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Xi'an, China
        • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
    • Beijing
      • Beijing, Beijing, China
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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:

    1. Total planned ablation volume of all fibroids should not exceed 250 ml, and
    2. No more than 5 fibroids should be planned for ablation, and
    3. Dominant fibroid (diameter) is greater than or equal to 3 cm, and
    4. Fibroids which are completely non-enhancing under Magnetic Resonance (MR) contrast agent should not be treated as the identification of treated volume becomes ambiguous
    5. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Philips Sonalleve MR-HIFU

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Healthcare

Investigators

  • Principal Investigator: Qinping Liao, Peking University First Hospital
  • Principal Investigator: Yueling Wang, First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 27, 2012

First Submitted That Met QC Criteria

April 27, 2012

First Posted (Estimate)

May 1, 2012

Study Record Updates

Last Update Posted (Estimate)

October 22, 2015

Last Update Submitted That Met QC Criteria

October 21, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 907764

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Fibroids

Clinical Trials on MR-HIFU uterine fibroid treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe