Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids

NCT00100191 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2005-06-24

No results posted yet for this study

Summary

The Emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization (UAE) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. UAE was considered equivalent to hysterectomy when at least 75% of patients had normalization of heavy menstrual blood loss after treatment.

Conditions

  • Menorrhagia
  • Leiomyoma
  • Uterine Neoplasms

Interventions

PROCEDURE

uterine artery embolization

PROCEDURE

hysterectomy

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY
  • ZonMw: The Netherlands Organisation for Health Research and Development

    lead OTHER

Principal Investigators

  • J.A. Reekers, MD, PhD · Academic Medical Centre, Department of Radiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Completion
2006-04-30

Countries

  • Netherlands

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 NCT00100191 on ClinicalTrials.gov