MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT00365989
First received: August 17, 2006
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

This is a phase 3 study to determine the safety of the new features to the FDA approved ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.


Condition Intervention Phase
Uterine Leiomyoma
Uterine Fibroids
Device: ExAblate 2000
Phase 3

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

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • The primary end point is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced. [ Time Frame: Within 1 month of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary end point of the study is to evaluate the ratio of normalized Enhanced Sonication thermal dose volume Vs. that of 'nominal' sonication. [ Time Frame: Within 1 month of treatment ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: October 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: ExAblate 2000

Detailed Description:

Uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape, and often highly vascular. On T2 weighted MR imaging exams, or T1 exams with contrast, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid. InSightec has developed an Enhanced Sonication (ES) technique for the ablation of these fibroids. This mode of tissue ablation has been added to the already FDA approved ExAblate system. The goal of this ES technique is to provide an additional treatment tool that will enhance the treatment effect without additional risks while preserving ALL clinical features of the current commercially approved version.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women age 18 or older, who present with symptomatic fibroids
  2. Women who have given written informed consent
  3. Women who are able and willing to attend all study visits.
  4. Patient is pre or peri-menopausal (within 12 months of last menstrual period).
  5. Able to communicate sensations during the ExAblate procedure.
  6. 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).
  7. Fibroids(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

  1. Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment
  2. Patient who desire to become pregnant in the future.
  3. Patients who are breast-feeding.
  4. Patients with an active pelvic inflammatory disease (PID)
  5. Active local or systemic infection
  6. Metallic implants that are incompatible with MRI
  7. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)
  8. Severe claustrophobia that would prevent completion of procedure in the MR unit.
  9. Extensive abdominal scarring in the beam pass or 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. Pedunculated fibroids.
  12. Intrauterine device (IUD) anywhere in the treatment path
  13. 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: NCT00365989

Locations
United States, California
University of California at San Diego
LaJolla, California, United States, 92037
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
KNI
Kalamazoo, Michigan, United States, 49048
United States, New York
Cornell Vascular
New York, New York, United States, 10022
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, MG5 2C4
Sponsors and Collaborators
InSightec
Investigators
Principal Investigator: Anne Roberts, M.D. University of California, San Diego
Principal Investigator: Mark Shaman, M.D. KNI
Principal Investigator: Robert Min, M.D. Cornell
Principal Investigator: David Gianfelice, M.D. Toronto General Hospital
Principal Investigator: George Holland, M.D. Lahey Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT00365989     History of Changes
Other Study ID Numbers: UF018
Study First Received: August 17, 2006
Last Updated: September 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by InSightec:
Fibroids
leiomyoma
neoplasm
benign tumors

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 21, 2014