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Trial record 1 of 1 for:    embosoft
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Uterine Artery Embolization With Microspheres in Patients With Leiomyoma. (EMBOSOFT I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03535610
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Scitech Produtos Medicos Ltda

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, 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 : August 13, 2018
Actual Primary Completion Date : February 20, 2020
Actual Study Completion Date : May 20, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Embolization
Uterine Embolization with PVA Microspheres
 Device: Uterine Embolization
Uterine Embolization with PVA Microspheres


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients with Uterine Leiomyoma
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535610


Locations
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Brazil
Certa Centro de Referência em Tratamentos Avançados
São Paulo, SP, Brazil, 01401-002
Sponsors and Collaborators
Scitech Produtos Medicos Ltda
More Information
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Responsible Party: Scitech Produtos Medicos Ltda
ClinicalTrials.gov Identifier: NCT03535610    
Other Study ID Numbers: SC-ES_001
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scitech Produtos Medicos Ltda:
Embolization
Uterine Leiomyoma
Embospheres
Microspheres
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases