Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization Compared to Embosphere for Symptomatic Relief From Uterine Fibroids
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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
United States: Food and Drug Administration
|Albany Medical Center||Albany, New York 12208|
|North Shore LIJ Medical Center||New Hyde Park, New York|