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Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent

NCT00361036 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2011-04-18

No results posted yet for this study

Summary

A double arm (non-inferiority) 44 patient study to assess the performance of BeadBlock™ in the treatment of uterine fibroids by embolization with respect to clinical \& imaging outcome with comparison of primary safety endpoints to Embosphere.

Conditions

  • Leiomyoma
  • Leiomyomatosis
  • Uterine Neoplasms

Interventions

DEVICE

Uterine fibroid embolization BeadBlock™

Intervention with BeadBlock Microspehere

DEVICE

Uterine fibroid embolization Embosphere®

Embosphere - control arm

Sponsors & Collaborators

  • Terumo Medical Corporation

    collaborator INDUSTRY

  • Biocompatibles UK Ltd

    collaborator INDUSTRY

  • Worthington-Kirsch, Robert L., M.D.

    lead INDIV

Principal Investigators

  • Robert Worthington-Kirsch, MD · Image Guided Surgery Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00361036 on ClinicalTrials.gov