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OpenTrials
Completed

NCT Number: NCT01153074

Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device

The purpose of this study is to evaluate the feasibility of closing bronchopleural fistulas with devices originally developed for correction of cardiac septal defects deployed through bronchoscopic procedures.

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Key information

Conditions

Bronchopleural Fistula

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Institute (InCor) Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo, São Paulo, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over 14 years old
  • Bronchopleural fistulas

Exclusion criteria

  • Clinical conditions increasing surgical risk (hemodynamic instability, respiratory distress)
  • Immunosuppressed patients
  • Acute intense inflammatory process in fistula edge
  • Suppurative pleural cavity infection

Treatment and study plan

Closure of bronchopleural fistula with Occlutech Figulla

Device

Patients with bronchopleural fistulas will be submitted to a bronchoscopic procedure to deploy the cardiac septal defect occluder in the fistula traject.

Other names: Bronchoscopic bronchopleural fistula closure with occluders

Primary outcomes

  1. Closure of tracheobronchial fistulas with the Occlutech Figulla ASD N occluder

    Time frame: 1 year

    The closure of the fistulas will be bronchoscopically observed at regular intervals: one week, three weeks, two months and six months.

    At the third months post intervention, a thorax CT scan will ascertain the correct position and stability of the device.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • InCor Heart Institute
  • Occlutech International AB

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Jun 29, 2010
Registry last updated
May 25, 2017

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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