Uterine Fibroid Clinical Trial
Official title:
Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.
The purpose of this post-market study is to evaluate UFE agents for the treatment of symptomatic uterine fibroids, using Gel-Bead compared to four other commonly used embolic agents.
This single-center, prospective study will be conducted at one site in the United Kingdom. Up
to 30 subjects will be enrolled and treated with Gel-Bead. Prospectively. Enrolled Gel-Bead
subjects will be followed at 1-month and 3-months post-procedure.
Data from subjects treated with Gel-Bead will be compared to data from a previously
unpublished, but widely presented, 100-patient cohort study at the University Hospital
Southampton. This study evaluated 20 subjects in five different treatment groups for the
treatment of symptomatic uterine fibroids. The five treatment groups include gelatin foam
slurry, Embospheres, polyvinyl alcohol (PVA), Bead Block and Embozenes.
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