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Clinical Trial Title
MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
Location and Contact Information
University of California at San Diego
Location and Contact Information
Lahey Clinic
Location and Contact Information
KNI
Location and Contact Information
Cornell Vascular
Location and Contact Information
Toronto General Hospital
Status Completed
Sponsors
InSightec
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.
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Eligibility
Genders Eligible for Study: Female
Ages eligible for study: 18 Years to N/A
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.
More Information
Study ID numbers:
UF018
ClinicalTrials Identifier - NCT00365989
For additional information, visit ClinicalTrials.gov.
Information obtained from ClinicalTrials.gov on 11/23/2009
This directory includes clinical trials that involve researchers at UCSD Medical
Center. The information was obtained from ClinicalTrials.gov, a database of the
U.S. National Institutes of Health.
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