Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma
NCT ID: NCT01468402
Last Updated: 2011-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
50 participants
OBSERVATIONAL
2008-09-30
2009-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Magnetic Resonanse Image
The leiomyomas were evaluated individually. MR was used to evaluate morphology: the radiological dimension(s) of the leiomyoma and uterus and the volume. The number of leiomyoma fibroid, and their location in the myometrium was classified. Perfusion and the characterization of the T2 signal were also evaluated.
Magnetic Resonance Image
The leiomyomas were evaluated individually. MR was used to evaluate morphology: the radiological dimension(s) of the leiomyoma and uterus and the volume. The number of leiomyoma fibroids was determined, and their location in the myometrium. Perfusion and the characterization of the T2 signal were also evaluated.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Magnetic Resonance Image
The leiomyomas were evaluated individually. MR was used to evaluate morphology: the radiological dimension(s) of the leiomyoma and uterus and the volume. The number of leiomyoma fibroids was determined, and their location in the myometrium. Perfusion and the characterization of the T2 signal were also evaluated.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* presence of symptoms (menorrhalgia and/or pelvic pain)
* indication for UAE(the desire to keep the uterus and/or contraindications for surgery).
Exclusion Criteria
* pelvic inflammatory disease
* allergy to iodinated contrast
* coagulopathy, renal failure
* vasculitis
* pelvic irradiation
* pregnancy
* subserosal leiomyoma with a pedicle smaller than 50% of diameter of the fibroid.
18 Years
45 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Sao Paulo
OTHER
Hospital Israelita Albert Einstein
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eduardo Zlotnik
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eduardo Zlotnik
Role: PRINCIPAL_INVESTIGATOR
Hospital Israelita Albert Einstein
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Affonso BB, Nasser F, de Jesus Silva SG, Silva MC, Zlotnik E, de Lorenzo Messina M, Baracat EC. [Strategies for reduction of exposure to ionizing radiation in women undergone to uterine fibroid embolization]. Rev Bras Ginecol Obstet. 2010 Feb;32(2):77-81. Portuguese.
Nasser F, Affonso BB, de Jesus-Silva SG, Coelho Dde O, Zlotnik E, Messina Mde L, Baracat EC. [Uterine fibroid embolization in women with giant fibroids]. Rev Bras Ginecol Obstet. 2010 Nov;32(11):530-5. doi: 10.1590/s0100-72032010001100003. Portuguese.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HIAE
Identifier Type: -
Identifier Source: org_study_id