Uterine Artery Embolization for Symptomatic Fibroids | NCT00354471

Studies
Uterine Artery Embolization for Symptomatic Fibroids

NCT00354471

Sponsor

University of Manitoba

Status

Completed

Last Update Posted

Feb 5, 2009Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Uterine Fibroids
Menorrhagia
Adenomyosis

Interventions

Uterine Artery Embolization

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 19, 2006

First Submission Date that Met QC Criteria

Jul 19, 2006

First Posted Date

Jul 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2009

Last Update Posted Date

Feb 5, 2009Estimated

Description Module

Brief Summary

This study will evaluate the safety, efficacy , quality of life and patient satisfaction of uterine artery embolization for the treatment of symptomatic uterine fibroids. It will provide useful information in the development od guidelines in patient selection, procedural management and subsequent follow up.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Uterine Artery Embolization	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptoms related to the pressence of uterine fibroids serious enough to consider surgical options
Confirmation of fibroids by endovaginal and transabdominal ultrasound

Exclusion Criteria:

Pedunculated fibroids
Desire for fertility
Carcinoma of pelvic organs
Previous pelvic irradiation
Bleeding diathesis and vasculitis
History of allergiy to contrst medium

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard S Boroditsky, MD	University of Manitoba	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Health Sciences Centre		Winnipeg	Manitoba	R3E 3P4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007889	Leiomyoma
D008595	Menorrhagia
D062788	Adenomyosis

Ancestor Terms

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055357	Uterine Artery Embolization

Ancestor Terms

ID	Term
D004621	Embolization, Therapeutic
D006489	Hemostatic Techniques
D013812	Therapeutics
D060205	Therapeutic Occlusion

Browse Leaves

Not provided

Browse Branches

Not provided