A Prospective, Randomized, Single-Center Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Number of Participants With Fibroid Devascularization Measured by Contrast Enhanced Magnetic Resonance Imaging (MRI)
MRI uses a large circular magnet and radio waves to generate signals from atoms in the body. These signals are used to construct images of internal structures. Injection of contrast through an IV is done during the test to enhance the view of the uterus. Contrast enhanced MRI was used as a test in this study to verify if blood supply to the fibroids was blocked or interrupted (devascularization).
24-hours post study procedure
No
Richard Shalansky-Goldberg, MD
Principal Investigator
University of Pennsylvania
United States: Institutional Review Board
M9011
NCT00628901
January 2006
January 2011
Name | Location |
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Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |