Magnetic Resonance Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids in Women Desiring Future Pregnancies
- 1. Subject with uterine fibroids, who desire pregnancy within 12 months and has the
one of the following criteria: Women 20-40 age. Women age < 46 years old who plan to
have egg donation. Women above 38 should test for normal ovarian function as judged
by endocrinological evaluation.
If the couple has failed to conceive for more that 1 year, the woman should test for
normal ovarian function as judged by endocrinological evaluation, and the male must have
adequate sperm test.
Women undergoing fertility treatment or plan to have sperm donation.
- 2. Use or non use of non-steroidal treatments for excessive vaginal bleeding such as
antifibrinolytic agents (e.g. Tranexamic acid) or non-steroidal anti-inflammatory
drugs (e.g. Mefanamic Acid) has been maintained for the three months prior to the
planned date of the study procedure and the patient has agreed to maintain this use
or non-use through the 6-month follow-up period.
- 3. Clinically normal PAP smear within timing of National Guidelines in the country of
the clinical site.
- 4. Able and willing to give consent and able to attend all study visits
- 5. Able to communicate sensations during the MRgFUS procedure
- 6. Having uterine fibroids that are device accessible (i.e., positioned in the uterus
such that they can be accessed without being shielded by bowel or bone).
- 7. Tumor(s) are clearly visible on non-contrast MRI.
- 8. Largest fibroid 8 cm in diameter or 12 cm if receiving GnRH
- 1. Patient is pregnant as confirmed by pregnancy test at time of screening
- 2. Uterine size >20 weeks as evaluated by US or MR.
- 3. Patients who are considered "high risk pregnancy" due to uterine factors (e.g.
abnormal uterus, uterine scars, cerclage) except fibroids.
- 4. Patients with fibroid that is more than 50% sub-mucosal or with hysteroscopically
- 5. Patients with adenomyosis
- 6. Patient is on dialysis
- 7. Hematocrit is < 25
- 8. Patient has hemolytic anemia
- 9. Patient has unstable cardiac status including: § Unstable angina pectoris on
medication§ Documented myocardial infarction within 6 months of protocol entry§
Congestive heart failure requiring medication (other than diuretic)§ Currently taking
anti-arrhythmic drugs§ Severe hypertension (diastolic BP>100 on medication)§ Presence
of cardiac pacemaker
- 10. Patient has an ASA score of >2
- 11. Patient has severe cerebrovascular disease (multiple CVA or CVA within 6 months)
- 12. Patient is on anti-coagulation therapy or has an underlying bleeding disorder
- 13. Evidence of uterine pathology other than leiomyoma
- 14. Patient has an active pelvic infection or history of pelvic inflammatory disease
- 15. Patient has an undiagnosed pelvic mass outside the uterus.
- 16. Patient weight >110 kg
- 17. Subject with extensive abdominal scarring in an area of the abdomen directly
anterior to the treatment area.
- 18. Subject with standard contraindications for MR imaging such as non-MRI compatable
implanted metallic devices.
- 19. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist).
- 20. Individuals who are not able or willing to tolerate the required prolonged
stationary prone position during treatment (approximately 3 hours.)
- 21. Patient with an intrauterine contraceptive device anywhere in the treatment beam
- 22. Women who are breast feeding.
- 23. Five or more fibroids, bigger then 3cm diameter, each