CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Uterine Fibroid Embolization (UFE) +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00628901
NCT00628901Phase 4Completed
CompareCT.gov

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

Boston Scientific Corporation·interventional·Posted Mar 5, 2008·Updated Jul 11, 2012

In Brief

A Phase 4 clinical trial evaluating Uterine Fibroid Embolization (UFE), Contour SE™ Microspheres, and 1 other intervention for Leiomyoma and 4 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeiomyoma, Uterine Fibroids, Uterine Neoplasms, Menorrhagia, Leiomyomatosis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 5, 2008
Enrollment StartJan 1, 2006
Primary CompletionDec 1, 2009
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 18.3 years ago

Interventions

Uterine Fibroid Embolization (UFE)procedure

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.

Contour SE™ Microspheresdevice

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

Embosphere® Microspheresdevice

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