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

University of Sao Paulo

Status: Completed

Conditions: Bronchopleural Fistula

Treatments: Device: Closure of bronchopleural fistula with Occlutech Figulla

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01153074

USP01089/09-TBF

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 14+ years old

Volunteers: No 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

Trial design

8 participants in 1 patient group

Occluder

Experimental group

Description:

The patients with bronchopleural fistulas treated with bronchoscopic deployment of the cardiac septal defects occluder.

Treatment:

Device: Closure of bronchopleural fistula with Occlutech Figulla