Embozene Microspheres for Uterine Fibroid Embolization (UFE)

Study Overview
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Brief Summary
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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.

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

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Device: Embozene® Microspheres
* Device: Embosphere®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embozene® Microspheres<br>Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink. | Device: Embozene® Microspheres<br> <br> |
| Active Comparator: Embosphere®<br>Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink. | Device: Embosphere®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint | The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months. | 12 Months post study procedure |