Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.
NCT ID: NCT03535610
Last Updated: 2020-09-04
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
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COMPLETED
NA
32 participants
INTERVENTIONAL
2018-08-13
2020-05-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Embolization
Uterine Embolization with PVA Microspheres
Uterine Embolization
Uterine Embolization with PVA Microspheres
Interventions
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Uterine Embolization
Uterine Embolization with PVA Microspheres
Eligibility Criteria
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Inclusion Criteria
* symptomatic uterine intramural leiomyomas or multiple symptomatic leiomyomas in the presence of intramural;
* patient agrees with study procedures;
* patient signs the informed consent form.
Exclusion Criteria
* isolated adenomyosis, pediculated subserous myoma, submucous leiomyoma (50% of uterine cavity diameter), intraligamentous leiomyoma;
* leiomyoma diameter higher than 10 cm;
* leiomyoma above the umbilical scar;
* endometrial neoplasia or hyperplasia or presence of any malignancy
* pregnant or breast feeding women;
* active vasculitis;
* pelvic irradiation history;
* uncontrolled coagulopathies;
* renal insufficiency;
* contrast allergy;
* concomitant use of GnRH analogues.
18 Years
50 Years
FEMALE
No
Sponsors
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Scitech Produtos Medicos Ltda
INDUSTRY
Responsible Party
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Locations
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Certa Centro de Referência em Tratamentos Avançados
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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SC-ES_001
Identifier Type: -
Identifier Source: org_study_id
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