Status:
COMPLETED
Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids
Lead Sponsor:
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Menorrhagia
Leiomyoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 eq...
Detailed Description
Uterine Artery Embolization (UAE) is a new treatment for heavy menstrual bleeding caused by uterine fibroids. UAE is already being performed on a regular basis, without profound evidence: no good qual...
Eligibility Criteria
Inclusion
- Uterine fibroids
- Menorrhagia
- Scheduled for hysterectomy
- Pre-menopausal
Exclusion
- Childwish (planning to conceive)
- Pregnancy
- Suspected malignancy
- Untreated pelvic inflammatory disease (PID)
- Clotting disorders
- Contrast fluid allergy
- Presence of intrauterine device (IUD)
- Renal failure (creatinine \> 150 mmol/l)
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00100191
Start Date
February 1 2002
End Date
April 1 2006
Last Update
June 24 2005
Active Locations (2)
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1
Academic Medical Centre Amsterdam
Amsterdam, Netherlands, 1105 AZ
2
27 Other Participating Hospitals of Varying Sizes Throughout the Country
Amsterdam, Netherlands