Safety Study of ExAblate for the Treatment of Uterine Fibroids

Exclusion Criteria

• •Women who are pregnant, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment.
• •Patients who are breast-feeding.
• •Patients with active pelvic inflammatory disease (PID).
• •Patients with active local or systemic infection.
• •Patients experiencing chronic leg or lower back pain within the last 6 months.
• •Contraindication for MRI Scan:
• •* Severe claustrophobia that would prevent completion of procedure in the MR unit
• •* Weight greater than 250 lbs (113Kg)
• •* Implanted ferromagnetic materials and/or devices contraindicated for MR scan
• •* Known intolerance to MRI contrast agent (e.g. Gadolinium or Magnevist)
• •* Any other contraindication for MRI Scan
• •Extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam).
• •Dermoid cyst of the ovary anywhere in the treatment path.
• •Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
• •Intrauterine device (IUD) anywhere in the treatment path.
• •Undiagnosed vaginal bleeding.
• •Pedunculated fibroids.
• •Uterine size \>24 weeks.