ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by InSightec
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT01285960
First received: January 27, 2011
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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 Intervention
Uterine Fibroid(s)
Device: ExAblate UF V2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by InSightec:

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

Estimated Enrollment: 106
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ExAblate treatment Device: ExAblate UF V2
Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285960

Locations
United States, California
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Fizaa Ahmed    650-725-6409    fizaa@stanford.edu   
Sub-Investigator: Pejman Ghanouni, M.D.         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Louise Greenberg    617-732-5441    LGREENBERG@PARTNERS.ORG   
Principal Investigator: Serene Srouji, M.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Patty Johnson, RN    507-538-7765    FOCUSEDULTRASOUND@mayo.edu   
Principal Investigator: Gina Hesley, MD         
United States, Ohio
Ohio Health Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Carol Strausbaugh, RN    614-566-1253    carol.strausbaugh@ohiohealth.com   
Principal Investigator: Eric Dolen, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Brigitte Kelly    434-243-0315    BJK3C@hscmail.mcc.virginia.edu   
Principal Investigator: Alan Matsumoto, MD         
Sponsors and Collaborators
InSightec
  More Information

Additional Information:
No publications provided

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT01285960     History of Changes
Other Study ID Numbers: UF031
Study First Received: January 27, 2011
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 01, 2014