A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
- 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.
- 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.