ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids

February 19, 2019 updated by: InSightec

A Clinical Study to Evaluate Safety of the ExAblate Model 2100 Type 1.1 System (ExAblate 2100/2000 UF V2 System) in the Treatment of Symptomatic Uterine Fibroids

The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids.

The ExAblate System is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each sonication is used to heat small spots in the fibroid much like a magnifying glass can be used to focus light to heat a spot. The heat created kills a portion of the fibroid with the goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are performed until the entire fibroid is treated or the treated volume is determined to be appropriate.

The ExAblate system is commercially approved in the United States to treat symptomatic uterine fibroids.

The ExAblate UF V2 System is an experimental device and is being investigated in this study. While similar to the commercial system, the ExAblate UF V2 device includes the following major changes, among others, which are intended to improve device performance and safety:

  • Up and down movement of the ultrasound transducer, in an attempt to improve fibroid treatment by moving the ultrasound focal point within the targeted fibroid.
  • Ultrasound energy can be turned off for a specific area in an attempt to minimize amount of energy passing through sensitive areas of the body.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

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
        • University of California, Los Angeles
      • San Francisco, California, United States, 94107
        • University of California, San Francisco
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Ohio Health 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 to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Patient age 18 or older
  2. Patients who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
  3. Patients who have given written informed consent
  4. Patients who are able and willing to attend all study visits
  5. Patients who are pre or peri-menopausal (within 12 months of last menstrual period)
  6. Patients should have completed child bearing
  7. Able to communicate sensations during the ExAblate procedure.
  8. 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).
  9. Fibroid(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

  1. Pregnant patients, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
  2. Uterine size >24 weeks.
  3. Patients with pedunculated fibroids
  4. Patients with active pelvic inflammatory disease (PID).
  5. Patients with active local or systemic infection
  6. Patients experiencing any symptoms of lower extremity neuropathy, including chronic leg or lower back pain, within the last 6 months

  7. Contraindication for MRI Scan:

    • Severe claustrophobia that would prevent completion of procedure in the MR unit
    • Metallic implants that are incompatible with MRI
    • Sensitivity to MRI contrast agents
    • Any other contraindication for MRI Scan
  8. Extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam)
  9. Dermoid cyst of the ovary anywhere in the treatment path.
  10. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
  11. Intrauterine device (IUD) anywhere in the treatment path
  12. Undiagnosed vaginal bleeding

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ExAblate treatment UF V2
ExAblate MRgFUS Treatment
Device: ExAblate Treatment UF V2
Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment
Time Frame: From treatment to 1-month post-treatment
The hypothesis for this study was that the percentage of subjects experiencing persistent leg pain would be less than 10%
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, 2012

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

January 27, 2011

First Submitted That Met QC Criteria

January 27, 2011

First Posted (ESTIMATE)

January 28, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 6, 2019

Last Update Submitted That Met QC Criteria

February 19, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF031

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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