Safety Study of ExAblate for the Treatment of Uterine Fibroids

Inclusion Criteria:

• Women age 18 or older
• Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)
• 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).
• Patient should be family complete.
• 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.
• Fibroid enhances on MR contrast imaging.

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.