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OpenTrials
Completed

NCT Number: NCT03535610

Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.

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

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Key information

Conditions

Uterine Leiomyoma Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Certa Centro de Referência em Tratamentos Avançados

São Paulo, 01401-002, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Uterine Embolization

Device

Uterine Embolization with PVA Microspheres

Primary outcomes

  1. Uterine Volume Reduction

    Time frame: 6 months

    Uterine Volume Reduction measured by MRI

  2. Fibroid Reduction

    Time frame: 6 months

    Fibroid Reduction measured by MRI

Secondary outcomes

  1. Quality of Life Improvement

    Time frame: 6 months

    Quality of Life Improvement measured by UFS-QOL

  2. Ovarian Function

    Time frame: 6 months

    Ovarian Function measured by Anti-Mullerian Hormon dosage pre and post-procedure

Sponsors and collaborators

Lead sponsor

Scitech Produtos Medicos SA

Industry

Registry information

Acronym: EMBOSOFT I

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 24, 2018
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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