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

University of Sao Paulo8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bronchopleural Fistula

Interventions

Closure of bronchopleural fistula with Occlutech FigullaDEVICE

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

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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

Locations (2)

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

São Paulo, Brazil

Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo

São Paulo, Brazil

Outcomes

Primary Outcomes

Closure of tracheobronchial fistulas with the Occlutech Figulla ASD N occluder

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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