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

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

Study Overview

• Status: Completed
• Conditions: Uterine Leiomyoma
• Intervention / Treatment: Device: Uterine Embolization

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 01401-002
      • Certa Centro de Referência em Tratamentos Avançados

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uterine Volume Reduction	Uterine Volume Reduction measured by MRI	6 months
Fibroid Reduction	Fibroid Reduction measured by MRI	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Improvement	Quality of Life Improvement measured by UFS-QOL	6 months
Ovarian Function	Ovarian Function measured by Anti-Mullerian Hormon dosage pre and post-procedure	6 months

Collaborators and Investigators

• Sponsor: Scitech Produtos Medicos Ltda

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Actual): February 20, 2020
• Study Completion (Actual): May 20, 2020

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Microspheres; Embolization; Uterine Leiomyoma; Embospheres
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: SC-ES_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No