Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.

NCT ID: NCT03535610

Last Updated: 2020-09-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-13

Study Completion Date

2020-05-20

Brief Summary

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To evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).

Detailed Description

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Conditions

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Uterine Leiomyoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, single-arm, open label study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Embolization

Uterine Embolization with PVA Microspheres

Group Type EXPERIMENTAL

Uterine Embolization

Intervention Type DEVICE

Uterine Embolization with PVA Microspheres

Interventions

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Uterine Embolization

Uterine Embolization with PVA Microspheres

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* female patients from 18 to 50 years old;
* 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

* asymptomatic women;
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Scitech Produtos Medicos Ltda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Certa Centro de Referência em Tratamentos Avançados

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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SC-ES_001

Identifier Type: -

Identifier Source: org_study_id

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