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

Bronchopleural Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153074
• Other study ID #: USP01089/09-TBF
• Status: Completed
• Phase: N/A
• First received: June 28, 2010
• Last updated: May 23, 2017
• Start date: June 2010
• Est. completion date: October 2016

Study information

• Verified date: May 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchopleural Fistula
• Fistula

Intervention

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.

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor) Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo	Sao Paulo
Brazil	Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	InCor Heart Institute, Occlutech International AB

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View Citation

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. English, Portuguese. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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