Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100191
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2004-12-23
Brief Title:
Emmy Trial Uterine Artery Embolization UAE Versus Hysterectomy for Uterine Fibroids
Sponsor:
ZonMw The Netherlands Organisation for Health Research and Development
Organization:
ZonMw The Netherlands Organisation for Health Research and Development
Study Overview
Official Title:
EMMY Trial a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 quality randomized controlled trials have been conducted The EMMY trial evaluates the safety and efficacy of UAE in a randomized comparison to hysterectomy Patients were included when they had uterine fibroids and menorrhagia and were eligible for hysterectomy The primary endpoint is the elimination of menorrhagia after a two-year follow-up period Secondary endpoints comprise effect on complaints of pain and pressure quality of life issues uterine volume reduction effect on ovarian function and cost-effectiveness Patients were randomly assigned to either UAE or hysterectomy 11 All patients were followed for two years after treatment Whether UAE can be an alternative to hysterectomy as treatment of first choice depends on the balance of efficacy costs and quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None