MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation

This study has been completed.
Sponsor:
Information provided by:
InSightec
ClinicalTrials.gov Identifier:
NCT00295217
First received: February 21, 2006
Last updated: January 13, 2009
Last verified: January 2009
  Purpose

The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.


Condition Intervention Phase
Uterine Fibroids
Uterine Leiomyomas
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: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Clinical Study to Validate the Changes to ExAblate 2000 Device

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • In this IDE for the 4.2 ExAblate system, the goal is evaluation of the new features to confirm that they do not introduce any new safety issues.

Estimated Enrollment: 15
Study Start Date: February 2006
Estimated Study Completion Date: October 2006
  Eligibility

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

Inclusion Criteria:

  1. Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
  2. Able and willing to give consent and able to attend all study visits.
  3. Patient is pre or peri-menopausal (within 12 months of last menstrual period).
  4. Able to communicate sensations during the ExAblate procedure.
  5. 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).
  6. Fibroids(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

  1. Metallic implants that are incompatible with MRI
  2. Sensitive to MRI contrast agents
  3. Severe claustrophobia that would prevent completion of procedure in MR unit
  4. Who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
  5. Pedunculated fibroids
  6. Active pelvic inflammatory disease (PID)
  7. Active local or systemic infection
  8. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia
  9. Intrauterine device (IUD) anywhere in the treatment path
  10. Dermoid cyst of the ovary anywhere in the treatment path
  11. Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)
  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: NCT00295217

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
Sponsors and Collaborators
InSightec
Investigators
Principal Investigator: George Holland, M.D. Lahey Clinic
Principal Investigator: Mark Shaman, M.D. KNI
Principal Investigator: Robert Min, M.D. Cornell
Principal Investigator: Anne Roberts, M.D. University of California, San Diego
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00295217     History of Changes
Other Study ID Numbers: UF017, Continued Access
Study First Received: February 21, 2006
Last Updated: January 13, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by InSightec:
Fibroids
Uterine Leiomyomas
ExAblate
MrgFUS

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 16, 2014