Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization Compared to Embosphere for Symptomatic Relief From Uterine Fibroids
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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
Yes
United States: Food and Drug Administration
2010-001
NCT01675011
August 2012
Name | Location |
---|---|
Albany Medical Center | Albany, New York 12208 |
North Shore LIJ Medical Center | New Hyde Park, New York |