Uterine FibroidsNCT00354471
Uterine Artery Embolization for Symptomatic Fibroids
An observational study of Uterine Fibroids and Menorrhagia, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Uterine Fibroids, Menorrhagia, Adenomyosis
- What is being tested?
- Uterine Artery Embolization
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Adult
Who may be able to join
- Symptoms related to the pressence of uterine fibroids serious enough to consider surgical options
- Confirmation of fibroids by endovaginal and transabdominal ultrasound
Who cannot join
- Pedunculated fibroids
- Desire for fertility
- Carcinoma of pelvic organs
- Previous pelvic irradiation
- Bleeding diathesis and vasculitis
- History of allergiy to contrst medium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short and Long Term Outcomes of Uterine Artery Embolization.
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.
- Conditions
- Uterine Fibroids, Menorrhagia, Adenomyosis
- Being tested
- Uterine Artery Embolization
- Medical subject headings
- Leiomyoma, Menorrhagia, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine Artery EmbolizationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- Richard S Boroditsky, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354471
- Sponsor's protocol ID
- B2000 115
- Status last verified
- Jul 2006
- First submitted
- 19 Jul 2006
- Last updated
- 5 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Outcomes of Uterine Artery Embolization.
- ClinicalTrials.gov ID
- NCT00354471
- Acronym / sponsor ID
- B2000 115
- Conditions
- Uterine Fibroids, Menorrhagia, Adenomyosis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- First posted
- 20 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Symptoms related to the pressence of uterine fibroids serious enough to consider surgical options
- Confirmation of fibroids by endovaginal and transabdominal ultrasound
Key exclusion criteria (6 listed)
- Pedunculated fibroids
- Desire for fertility
- Carcinoma of pelvic organs
- Previous pelvic irradiation
- Bleeding diathesis and vasculitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine Artery Embolization | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard S Boroditsky, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroids and Menorrhagia, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2009.