Safety Study of ExAblate for the Treatment of Uterine Fibroids

March 5, 2019 updated by: InSightec

A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques

The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines. Treatment may include up to 100% of individual fibroid volume, within established serosal and sacral treatment margins.

The Enhanced sonication is one of the various sonication modes that may lead to increased thermal dose volume of each sonication without additional safety risks. This is an additional treatment tool available in the ExAblate system for the treatment of uterine fibroids.

The safety profile of the Enhanced Sonication was investigated under an FDA-regulated IDE study. FDA granted approval of Enhanced Sonication with the requirement to perform a post-approval study to collect additional safety data when treating up to 100% of individual fibroid volume.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

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

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA
      • San Diego, California, United States, 92103-8749
        • UCSD Department of Radiology
      • San Francisco, California, United States, 94107
        • University of California San Francisco
    • Florida
      • Boca Raton, Florida, United States, 33431
        • University Image Guided Therapy
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Research Institute
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital Research Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women age 18 or older
  • Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)
  • Women who have given written informed consent
  • Women who are able and willing to attend all study visits.
  • Patient is pre or peri-menopausal (within 12 months of last menstrual period).
  • Patient should be family complete.
  • Able to communicate sensations during the ExAblate procedure.
  • Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).
  • Fibroids(s) clearly visible on non-contrast MRI.
  • Fibroid enhances on MR contrast imaging.

Exclusion Criteria:

  • Women who are pregnant, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment.
  • Patients who are breast-feeding.
  • Patients with active pelvic inflammatory disease (PID).
  • Patients with active local or systemic infection.
  • Patients experiencing chronic leg or lower back pain within the last 6 months.

  • Contraindication for MRI Scan:

    • Severe claustrophobia that would prevent completion of procedure in the MR unit
    • Weight greater than 250 lbs (113Kg)
    • Implanted ferromagnetic materials and/or devices contraindicated for MR scan
    • Known intolerance to MRI contrast agent (e.g. Gadolinium or Magnevist)
    • Any other contraindication for MRI Scan
  • Extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam).
  • Dermoid cyst of the ovary anywhere in the treatment path.
  • Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
  • Intrauterine device (IUD) anywhere in the treatment path.
  • Undiagnosed vaginal bleeding.
  • Pedunculated fibroids.
  • Uterine size >24 weeks.

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
Other: ExAblate treatment
Device: ExAblate
Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Occurrence of Chronic Leg Pain
Time Frame: From treatment to 1-month post-treatment
The hypothesis was that over 90% of subjects would not experience chronic leg pain. A lower 95% Confidence Limit > 0.90 was considered statistically successful.
From treatment to 1-month post-treatment

Collaborators and Investigators

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

Sponsor

InSightec

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.

Helpful Links

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, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimate)

June 11, 2010

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF033

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.

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