EMBOSOFT I: Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.

Sponsor

Scitech Produtos Medicos Ltda (Industry)

Overall Status

Completed

CT.gov ID

NCT03535610

Collaborator

(none)

Enrollment

Location

Arm

21.2

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Uterine Leiomyoma	Device: Uterine Embolization	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, single-arm, open label studyProspective, single-arm, open label study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.

Actual Study Start Date :

Aug 13, 2018

Actual Primary Completion Date :

Feb 20, 2020

Actual Study Completion Date :

May 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Embolization Uterine Embolization with PVA Microspheres	Device: Uterine Embolization Uterine Embolization with PVA Microspheres

Arm

Intervention/Treatment

Experimental: Embolization

Uterine Embolization with PVA Microspheres

Device: Uterine Embolization

Uterine Embolization with PVA Microspheres

Outcome Measures

Primary Outcome Measures

Uterine Volume Reduction [6 months]
Uterine Volume Reduction measured by MRI
Fibroid Reduction [6 months]
Fibroid Reduction measured by MRI

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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.