Leiomyoma Clinical Trial
Official title:
Feasibility Evaluation of the Embolic Agent BeadBlock™ in the Treatment of Uterine Fibroids With Uterine Artery Embolization With Comparison of Study Endpoints to Embosphere®
A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlock™ in the treatment of uterine fibroids by embolization with respect to clinical & imaging outcome with comparison of primary safety endpoints to Embosphere.
The purpose of the study is to conduct a comparison between BeadBlock™ and Embosphere in
uterine fibroid embolization. Baseline and follow-up MR Imaging data will be made with
respect to changes in fibroid and uterus perfusion and fibroid and uterine volume. This is a
12 months study (12 month follow up for all enrollees). The primary end-point will be the
degree of fibroid devascularization as seen at contrast-enhanced MRI performed 3 months (+/-
15 days) after UAE procedure. In addition we will assess symptom reduction in patients that
have undergone uterine fibroid embolization with Bead Block™ and Embosphere®.
Primary Objective 1. To assess the change in fibroid devascularization as seen at
contrast-enhanced MRI performed after UAE and at three (3) months (+/- 15 days) following
the UAE, and compare the changes between BeadBlock™ and Embosphere.
Secondary Objective
1. To assess the change in fibroid devascularization as seen at contrast-enhanced MRI
performed several days after UAE and 6 months (+/- 15 days) following the UAE, and compare
the changes between BeadBlock™ and Embosphere.
Tertiary Objective
1. To assess the change in uterine volume as seen at contrast-enhanced MRI performed
several days after UAE, 3 months (+/- 15 days) and 6 months (+/- 15 days) following the
UAE, and compare the changes between BeadBlock™ and Embosphere.
2. To assess the change from baseline in symptom severity (UFS-QOL)at 3, 6 and 12 months
(+/- 15 days) follow-up, as measured by the subscale of the UFS questionnaire, and
compare the changes between BeadBlock™ and Embosphere.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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