ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01285960
Recruitment Status : Completed
First Posted : January 28, 2011
Last Update Posted : April 13, 2016
Information provided by (Responsible Party):

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Device: ExAblate Treatment UF V2 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

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.

Primary Outcome Measures :
  1. Leg pain or lower extremity neuropathy persisting or occuring greater than 10 days following treatment [ Time Frame: From treatment to 1-month post-treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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. Demoid 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01285960

United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, California, United States, 94107
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, Ohio
Ohio Health Research Institute
Columbus, Ohio, United States, 43214
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators

Responsible Party: InSightec Identifier: NCT01285960     History of Changes
Other Study ID Numbers: UF031
First Posted: January 28, 2011    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016

Keywords provided by InSightec:
Uterine fibroids
Focused Ultrasound
Symptomatic uterine fibroids

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases