Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device
|ClinicalTrials.gov Identifier: NCT01153074|
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : May 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bronchopleural Fistula||Device: Closure of bronchopleural fistula with Occlutech Figulla||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||October 2016|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|