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| Name | Class |
|---|---|
| InCor Heart Institute | OTHER |
| Occlutech International AB | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Occluder | Experimental | The patients with bronchopleural fistulas treated with bronchoscopic deployment of the cardiac septal defects occluder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closure of bronchopleural fistula with Occlutech Figulla | Device | Patients with bronchopleural fistulas will be submitted to a bronchoscopic procedure to deploy the cardiac septal defect occluder in the fistula traject. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel L. Tedde, MD, PhD | Heart Institute (InCor) HC of the Sao Paulo University School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute (InCor) Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo | São Paulo | 05403-900 | Brazil | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21896530 | Result | Tedde ML, Scordamaglio PR, Rodrigues A, Minamoto H, Alfinito FS. Minimally invasive closure of bronchopleural fistulas. Chest. 2011 Sep;140(3):826. doi: 10.1378/chest.11-0719. No abstract available. | |
| 21440188 | Result | Tedde ML, Minamoto H, Scordamaglio PR, Rodrigues A, Moura EG, Pedra CA. Broncoscopic closure of tracheoesophageal fistulas. Ann Thorac Surg. 2011 Apr;91(4):1311. doi: 10.1016/j.athoracsur.2010.09.015. No abstract available. |
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| Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo |
| São Paulo |
| Brazil |
| 20011853 | Result | Scordamaglio PR, Tedde ML, Minamoto H, Pedra CA, Jatene FB. Endoscopic treatment of tracheobronchial tree fistulas using atrial septal defect occluders: preliminary results. J Bras Pneumol. 2009 Nov;35(11):1156-60. doi: 10.1590/s1806-37132009001100015. English, Portuguese. |
| 28082466 | Result | Scordamaglio PR, Tedde ML, Minamoto H, Assad RS, Fernandes PMP. Can total bronchopleural fistulas from complete stump dehiscence be endoscopically treated? Eur J Cardiothorac Surg. 2017 Apr 1;51(4):702-708. doi: 10.1093/ejcts/ezw377. |