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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01153074

Enrollment

Registered

2010-06-29

Start date

2010-06-30

Completion date

2016-10-31

Last updated

2017-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopleural Fistula

Keywords

Bronchopleural fistula, Bronchoscopy

Brief summary

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.

Interventions

DEVICEClosure of bronchopleural fistula with Occlutech Figulla

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

Study design

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Closure of tracheobronchial fistulas with the Occlutech Figulla ASD N occluder	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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026