Uterine Artery Embolization With Microspheres in Patients With Leiomyoma. (EMBOSOFT I)

Scitech Produtos Medicos

Status: Completed

Conditions: Uterine Leiomyoma

Treatments: Device: Uterine Embolization

Study type: Interventional

Funder types: Industry

Identifiers

NCT03535610

SC-ES_001

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Embolization

Experimental group

Description:

Uterine Embolization with PVA Microspheres

Treatment:

Device: Uterine Embolization