MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids

Completed · Not applicable

Conditions studied: Uterine Fibroids

In brief

This is a prospective, nonrandomized, multi-center study to evaluate the safety and effectiveness of ExAblate in the treatment of uterine fibroids. All patients will be treated and then followed for 36 months to evaluate the change in their fibroid symptoms.

Key facts

Study ID

NCT00166270

Run by

InSightec

People needed

70

Starts

2005-01-01

Expected to finish

2009-01-01

Last updated by the study team

2018-07-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
• Able and willing to give consent and able 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…

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

Where it is running

• Radnet Management — Los Angeles, California, United States
• University MRI — Boca Raton, Florida, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Virtua — Voorhees Township, New Jersey, United States
• North Texas Uterine Fibroid Institute — Plano, Texas, United States

Full record on ClinicalTrials.gov

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