Safety Study of ExAblate for the Treatment of Uterine Fibroids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT01142791
First received: June 10, 2010
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Uterine Fibroids
Device: ExAblate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques

Further study details as provided by InSightec:

Primary Outcome Measures:
  • Chronic leg pain [ Time Frame: From treatment to 1-month post-treatment ] [ Designated as safety issue: Yes ]

Enrollment: 115
Study Start Date: May 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ExAblate treatment Device: ExAblate
Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01142791

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

Additional Information:
No publications provided

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT01142791     History of Changes
Other Study ID Numbers: UF033
Study First Received: June 10, 2010
Last Updated: July 28, 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 August 28, 2014