MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication

Completed · Phase 3

Conditions studied: Uterine Leiomyoma, Uterine Fibroids

In brief

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.

Key facts

Study ID

NCT00365989

Run by

InSightec

People needed

50

Starts

2006-10-01

Expected to finish

2008-08-01

Last updated by the study team

2019-02-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California at San Diego — La Jolla, California, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• KNI — Kalamazoo, Michigan, United States
• Cornell Vascular — New York, New York, United States
• Toronto General Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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