Status:
COMPLETED
MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
Lead Sponsor:
InSightec
Conditions:
Uterine Leiomyoma
Uterine Fibroids
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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.
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 exam...
Eligibility Criteria
Inclusion
- Women age 18 or older, who present with symptomatic fibroids
- 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).
- 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.
Exclusion
- Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment
- Patient who desire to become pregnant in the future.
- Patients who are breast-feeding.
- Patients with an active pelvic inflammatory disease (PID)
- Active local or systemic infection
- Metallic implants that are incompatible with MRI
- Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)
- Severe claustrophobia that would prevent completion of procedure in the MR unit.
- Extensive abdominal scarring in the beam pass or dermoid cyst of the ovary anywhere in the treatment path.
- Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
- Pedunculated fibroids.
- Intrauterine device (IUD) anywhere in the treatment path
- Undiagnosed vaginal bleeding.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00365989
Start Date
October 1 2006
End Date
August 1 2008
Last Update
February 5 2019
Active Locations (5)
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1
University of California at San Diego
La Jolla, California, United States, 92037
2
Lahey Clinic
Burlington, Massachusetts, United States, 01805
3
KNI
Kalamazoo, Michigan, United States, 49048
4
Cornell Vascular
New York, New York, United States, 10022