Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids
EMMY Trial: a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids
1 other identifier
interventional
120
1 country
2
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 equivalent to hysterectomy when at least 75% of patients had normalization of heavy menstrual blood loss after treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2002
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 23, 2004
CompletedFirst Posted
Study publicly available on registry
December 24, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedJune 24, 2005
December 1, 2004
December 23, 2004
June 23, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
Secondary Outcomes (7)
Effect on complaints of pain and pressure
Technical failure
Complications
Quality of life issues
Uterine volume reduction
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Uterine fibroids
- Menorrhagia
- Scheduled for hysterectomy
- Pre-menopausal
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Academic Medical Centre Amsterdam
Amsterdam, 1105 AZ, Netherlands
27 Other Participating Hospitals of Varying Sizes Throughout the Country
Amsterdam, Netherlands
Related Publications (2)
Hehenkamp WJ, Volkers NA, Van Swijndregt AD, De Blok S, Reekers JA, Ankum WM. Myoma expulsion after uterine artery embolization: complication or cure? Am J Obstet Gynecol. 2004 Nov;191(5):1713-5. doi: 10.1016/j.ajog.2004.02.001.
PMID: 15547547RESULTHehenkamp WJ, Volkers NA, Bartholomeus W, de Blok S, Birnie E, Reekers JA, Ankum WM. Sexuality and body image after uterine artery embolization and hysterectomy in the treatment of uterine fibroids: a randomized comparison. Cardiovasc Intervent Radiol. 2007 Sep-Oct;30(5):866-75. doi: 10.1007/s00270-007-9121-7.
PMID: 17671809DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J.A. Reekers, MD, PhD
Academic Medical Centre, Department of Radiology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 23, 2004
First Posted
December 24, 2004
Study Start
February 1, 2002
Study Completion
April 1, 2006
Last Updated
June 24, 2005
Record last verified: 2004-12