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

Inclusion criteria

• 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.

Exclusion criteria

• 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