A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)

PHASE4CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

December 31, 2009

Study Completion Date

January 31, 2011

Conditions
LeiomyomaUterine FibroidsUterine NeoplasmsMenorrhagiaLeiomyomatosis
Interventions
PROCEDURE

Uterine Fibroid Embolization (UFE)

Uterine Fibroid Embolization is used in treating Uterine Fibroids. The procedure involves injecting embolization particles into the fibroid via the uterine artery which causes the fibroid to shrink or subside. Patients are usually released from the hospital the day after the procedure.

DEVICE

Contour SE™ Microspheres

Polyvinyl alcohol Microsphere embolization devices intended to provide targeted vascular occlusion or reduction of blood flow upon selective placement and are currently marketed for use in hypervascular tumors, including leiomyoma uteri and arteriovenous malformations

DEVICE

Embosphere® Microspheres

Biocompatible, hydrophilic, nonresorbable, microspheres used in the embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.

Trial Locations (1)

19104-3246

Hospital of the University of Pennsylvania, Philadelphia

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY

NCT00628901 - A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE) | Biotech Hunter | Biotech Hunter