Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device
|Bronchopleural Fistula||Device: Closure of bronchopleural fistula with Occlutech Figulla|
|Study Design:||Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device|
- 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.
|Study Start Date:||June 2010|
|Study Completion Date:||October 2016|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
The patients with bronchopleural fistulas treated with bronchoscopic deployment of the cardiac septal defects occluder.
Device: Closure 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.
Other Name: Bronchoscopic bronchopleural fistula closure with occluders
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153074
|Heart Institute (InCor) Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo|
|Sao Paulo, Brazil, 05403-900|
|Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo|
|Sao Paulo, Brazil|
|Principal Investigator:||Miguel L. Tedde, MD, PhD||Heart Institute (InCor) HC of the Sao Paulo University School|