Embozene Microspheres for Uterine Fibroid Embolization (UFE)

Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization Compared to Embosphere for Symptomatic Relief From Uterine Fibroids

This is a randomized, prospective, multi-center study of 225 female subjects age 30-50 years with symptoms from uterine fibroids. All subjects will be followed for a total of thirty-six (36) months following uterine fibroid embolization.

Inclusion Criteria:

• Subject is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form.
• Pre-menopausal women age 30-50 years at time of enrollment
• Have been selected forUterine Fibroid Embolization (UFE) prior to entry to the study.

Exclusion Criteria:

• Patient has a history of pelvic malignancy
• Patient has an abnormal Pap smear within 12 months of the planned Uterine Fibroid Embolization procedure
• Patient with coexisting condition that might explain abnormal bleeding (including endometrial hyperplasia and adenomyosis) or pelvic pain (including endometriosis and ovarian cysts).
• Is at substantial risk for the need of organ transplantation, such as renal insufficiency.
• Patient has evidence of current or recent pelvic inflammatory disease or uterine infection.
• Patient with a severe contrast allergy or renal insufficiency that would represent a contradiction to the administration of iodine-based contrast agents.
• Patients unable to comply with the follow-up requirements of the study.