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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
4
Albany Medical Center
Albany, New York, United States
North Shore LIJ Medical Center
New Hyde Park, New York, United States
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.
Time frame: 12 Months post study procedure
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