Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization

This is an interventional treatment trial for Uterine Fibroids focused on measuring Uterine Fibroids, Embolization Read More

Inclusion Criteria:

1. She is able to provide informed consent and sign the Institutional Review Board approved informed consent form.
2. She is pre-menopausal and 30-50 years of age at the time of enrollment.
3. She is not actively attempting to become pregnant for a minimum of 1 year after UFE, or practicing abstinence and willing to continue for a minimum of 1 year after UFE, or is surgically sterile.
4. She is suffering from clinically significant symptoms attributed to the presence of uterine fibroids including abnormal menstrual bleeding and/or bulk-related symptoms including pelvic pain/discomfort, abdominal distension, urinary symptoms (including but not limited to increased urinary frequency or urinary hesitancy), and/or dyspareunia.

Exclusion Criteria:

1. She has a history of pelvic malignancy.
2. She is pregnant or intends to become pregnant within 12 months of the planned UFE procedure.
3. She has had an abnormal PAP smear (anything other than normal or ASCUS - Atypical Squamous Cells of Unknown Significance) within 12 months of the planned UFE procedure.
4. She has a coexisting condition that might explain the presenting symptoms (including but not limited to adenomyosis, endometrial hyperplasia, endometriosis, and complex ovarian cysts).
5. She has evidence of current or recent pelvic inflammatory disease or uterine infection.
6. She has another serious medical condition that might preclude full participation in the study to the desired endpoint (e.g., uncontrolled diabetes, malignancy, chronic obstructive pulmonary disease, myocardial infarction, congestive heart failure, etc.)
7. She has a severe contrast allergy or renal insufficiency that would represent a contraindication to the administration of iodine-based or gadolinium-based contrast agents.
8. She has a contraindication to magnetic resonance imaging (MRI).
9. She has one or more MRI findings including a uterine size >20 cm in greatest length, a dominant fibroid with a greatest diameter >12 cm, an intracavitary submucosal fibroid, or non enhancing dominant fibroids.
10. In the judgment of the investigator, she is unable or unlikely to be able to comply with the study procedures and requirements.