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
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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