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The purpose of this study is to demonstrate comparability between Contour SE™ Microspheres and Embosphere® Microspheres for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids.
The purpose of this prospective randomized single-center study is to demonstrate comparability using Contour SE™ Microspheres (700-900µ and 900-1200µ) using a near stasis endpoint and Embosphere® Microspheres (500-700µ) using a "prune tree" endpoint for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids. The study will demonstrate (with the use of contrast enhanced Magnetic Resonance Imaging (MRI) at baseline and 24-hours post embolization) that uterine fibroids can successfully be devascularized using the embolization protocols. Contrast enhanced MRI will be performed at baseline, 24-hours, and 3-months post UFE. The subjects will be followed through 12-months post UFE and change from baseline in symptom severity (Quality of Life (QoL) Questionnaire) will be assessed at 3 months and 12 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Uterine Fibroid Embolization (UFE), Contour SE™ Microspheres, Embosphere® Microspheres
Hospital of the University of Pennsylvania
Boston Scientific Corporation
Published on BioPortfolio: 2014-08-27T03:32:26-0400
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The use of embolizing agents to block the arterial blood supply to parts or all of the UTERUS. The procedures are done to control bleeding or to cause destruction of uterine tissues.
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A biocompatible, hydrophilic, inert gel that is permeable to tissue fluids. It is used as an embedding medium for microscopy, as a coating for implants and prostheses, for contact lenses, as microspheres in adsorption research, etc.
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Surgical removal of a LEIOMYOMA of the UTERUS.
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