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

Primary Purpose

Uterine Leiomyoma

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Uterine Embolization
Sponsored by
Scitech Produtos Medicos Ltda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Leiomyoma focused on measuring Embolization, Uterine Leiomyoma, Embospheres, Microspheres

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Certa Centro de Referência em Tratamentos Avançados

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Embolization

Arm Description

Uterine Embolization with PVA Microspheres

Outcomes

Primary Outcome Measures

Uterine Volume Reduction
Uterine Volume Reduction measured by MRI
Fibroid Reduction
Fibroid Reduction measured by MRI

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2018
Last Updated
September 3, 2020
Sponsor
Scitech Produtos Medicos Ltda
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1. Study Identification

Unique Protocol Identification Number
NCT03535610
Brief Title
Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.
Acronym
EMBOSOFT I
Official Title
Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
May 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scitech Produtos Medicos Ltda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Leiomyoma
Keywords
Embolization, Uterine Leiomyoma, Embospheres, Microspheres

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, single-arm, open label study
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Embolization
Arm Type
Experimental
Arm Description
Uterine Embolization with PVA Microspheres
Intervention Type
Device
Intervention Name(s)
Uterine Embolization
Intervention Description
Uterine Embolization with PVA Microspheres
Primary Outcome Measure Information:
Title
Uterine Volume Reduction
Description
Uterine Volume Reduction measured by MRI
Time Frame
6 months
Title
Fibroid Reduction
Description
Fibroid Reduction measured by MRI
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life Improvement
Description
Quality of Life Improvement measured by UFS-QOL
Time Frame
6 months
Title
Ovarian Function
Description
Ovarian Function measured by Anti-Mullerian Hormon dosage pre and post-procedure
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients with Uterine Leiomyoma
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Certa Centro de Referência em Tratamentos Avançados
City
São Paulo
State/Province
SP
ZIP/Postal Code
01401-002
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.

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