A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids
1. Women age 18 or older
2. Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher,
based on patient responses to questions 1-8 (raw score) of the Uterine Fibroid
Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL).
3. Women who have given written informed consent
4. Women who are able and willing to attend all study visits
5. Patient is pre or peri-menopausal (within 12 months of last menstrual period)
6. Able to communicate sensations during the ExAblate procedure
7. Uterine fibroids, which are device accessible
8. Fibroid(s) clearly visible on non-contrast MRI.
9. Fibroid(s) enhances on MR contrast imaging
1. Women currently pregnant
2. Uterine size > 24 cm W/O the cervix
3. More than 4 clinically significant fibroids (per MRI)
4. Prior myomectomy, UAE
5. Allergy to either gadolinium or iodinated contrast
6. Implanted metallic device prohibiting MRI
7. Severe claustrophobia
8. Active pelvic infection
9. Current use of intrauterine contraceptive device
10. Unstable medical conditions requiring additional monitoring during the procedure
11. Bleeding diathesis requiring medical treatment
12. Imaging suggestive of malignant disease of uterus, ovary, or cervix
13. Imaging and suggestive of adenomyosis.
14. Pedunculated submucosal or pedunculated subserosal myoma
15. Size and weight which prohibits subject from fitting in MRI device
16. Unavoidable, scarring, skin folds or irregularity, bowel, pubic bone, IUD, surgical
clips or hard implants in the beam path.
17. Hyper intense fibroid relatively to the uterus muscle
18. Women with ovarian dermoid cyst anywhere in the treatment path