Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.

Not Applicable

Completed

• Conditions: Uterine Leiomyoma
• Interventions: Device: Uterine Embolization

• Registration Number: NCT03535610
• Lead Sponsor: Scitech Produtos Medicos Ltda

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-24
• Study Start: 2018-08-13
• Primary Completion: 2020-02-20
• Study Completion: 2020-05-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Embolization	Uterine Embolization	Uterine Embolization with PVA Microspheres

Primary Outcome Measures

Name	Time	Method
Uterine Volume Reduction	6 months	Uterine Volume Reduction measured by MRI
Fibroid Reduction	6 months	Fibroid Reduction measured by MRI

Secondary Outcome Measures

Name	Time	Method
Ovarian Function	6 months	Ovarian Function measured by Anti-Mullerian Hormon dosage pre and post-procedure
Quality of Life Improvement	6 months	Quality of Life Improvement measured by UFS-QOL

Trial Locations

Locations (1)

Certa Centro de Referência em Tratamentos Avançados; 🇧🇷 São Paulo, SP, Brazil