Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.

Uterine Leiomyoma Clinical Trial

— EMBOSOFT I  

Official title:

Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535610
• Other study ID #: SC-ES_001
• Status: Completed
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: May 20, 2020

Study information

• Verified date: September 2020
• Source: Scitech Produtos Medicos Ltda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Leiomyoma

Intervention

Device:
• Uterine Embolization
Uterine Embolization with PVA Microspheres

Locations

Country	Name	City	State
Brazil	Certa Centro de Referência em Tratamentos Avançados	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Scitech Produtos Medicos Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine Volume Reduction	Uterine Volume Reduction measured by MRI	6 months
Primary	Fibroid Reduction	Fibroid Reduction measured by MRI	6 months
Secondary	Quality of Life Improvement	Quality of Life Improvement measured by UFS-QOL	6 months
Secondary	Ovarian Function	Ovarian Function measured by Anti-Mullerian Hormon dosage pre and post-procedure	6 months