Uterine Fibroids Clinical Trial
Official title:
Safety and Efficacy of Embozene® Microspheres for Uterine Fibroid Embolization Compared to Embosphere® Microspheres for Symptomatic Relief From Uterine Fibroids
The purpose of this study is to evaluate the safety and effectiveness of Embozene Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine fibroids. A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6 sites. Symptom severity, health-related quality of life, and the appearance of the fibroids will be assessed prior to treatment. Patients will then undergo the uterine fibroid embolization procedure with either Embosphere Microspheres or Embozene Microspheres, which will be randomly assigned. Clinical outcomes will be assessed 1 month, 3 months, 6 months and 12 months after the procedure, and imaging outcomes will be obtained 3 months after the procedure.
The uterine fibroid embolization (UFE) procedure is an accepted, minimally invasive
treatment option for patients with symptomatic uterine fibroids. Studies evaluating the
outcomes after this procedure have established that the use of polyvinyl alcohol particles
and Embosphere Microspheres is associated with best clinical and imaging outcomes. Embozene
Microspheres represent a new embolic agent that is being evaluated for use for the treatment
of symptomatic fibroids. The purpose of this study is to evaluate the safety and
effectiveness of Embozene Microspheres compared with Embosphere Microspheres for the
treatment of symptomatic uterine fibroids.
A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6 sites. A
questionnaire designed to assess symptom severity and health-related quality of life in
patients will be administered to patients at the time of enrollment. In addition, a
contrast-enhanced magnetic resonance imaging (MRI) examination will be performed to confirm
the diagnosis of fibroids. Patients will then undergo the uterine fibroid embolization
procedure. The embolic agent used for the procedure (Embosphere Microspheres or Embozene
Microspheres) will be randomly assigned. Patients will be seen 1 month, 3 months, and 6
months and contacted 12 months after the procedure so that the same questionnaire can be
used to assess clinical outcomes. In addition, an MRI will be performed 3 months after the
procedure to determine the imaging response to treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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