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uterine artery embolization, hysterectomy

Phase 3

Menorrhagia | Unknown | Oncology |Boston Scientific Corporation|Last Updated: Jun 24, 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

uterine artery embolization, hysterectomy · 1 trial · 3 indications

Phase 3 1
NCT00100191Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine FibroidsMenorrhagia
COMPLETED120 Analytics
PHASE3COMPLETED
Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids
MenorrhagiaUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary endpoint is the normalization of menorrhagia after a two-year follow-up period

Secondary Endpoints

Effect on complaints of pain and pressure
Technical failure
Complications
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
uterine artery embolizationPROCEDURE -
hysterectomyPROCEDURE -
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Uterine fibroids * Menorrhagia * Scheduled for hysterectomy * Pre-menopausal Exclusion Criteria: * Childwish (planning to conceive) * Pregnancy * Suspected malignancy * Untreated pelvic inflammatory disease (PID) * Clotting disorders * Contrast fluid allergy * Presence of in...

Countries:Netherlands
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Frequently asked questions about uterine artery embolization, hysterectomy

What is uterine artery embolization and hysterectomy used for?

Uterine artery embolization and hysterectomy are used for menorrhagia, or heavy menstrual bleeding, often associated with uterine fibroids. The Emmy Trial studied these procedures in women with menorrhagia, leiomyoma, and uterine neoplasms. The trial enrolled 120 female participants aged 18 years and older in the Netherlands.

Who makes uterine artery embolization and hysterectomy?

Boston Scientific Corporation (ticker: BSX) is the developer of uterine artery embolization and hysterectomy. The company conducted the Emmy Trial, a Phase 3 study comparing these procedures for the treatment of menorrhagia and uterine fibroids.

What phase is uterine artery embolization and hysterectomy in?

Uterine artery embolization and hysterectomy are in Phase 3 clinical development. The Emmy Trial, a Phase 3 study, has been completed. The procedures remain investigational for the treatment of menorrhagia and are not stated to be FDA approved.

What clinical trials is uterine artery embolization and hysterectomy in?

Uterine artery embolization and hysterectomy were studied in the Emmy Trial, registered as NCT00100191. This Phase 3 trial compared uterine artery embolization versus hysterectomy for uterine fibroids in women with menorrhagia. The trial enrolled 120 participants and has been completed.

Is uterine artery embolization and hysterectomy the same as UAE and hysterectomy?

Yes, uterine artery embolization is commonly abbreviated as UAE. The Emmy Trial, NCT00100191, compared uterine artery embolization (UAE) versus hysterectomy for uterine fibroids. Both procedures are used to treat menorrhagia and related uterine conditions.