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

NCT01153074 | Completed DMC

• 1 other identifier: USP01089/09-TBF
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bronchopleural Fistula

Keywords

Bronchopleural fistula; Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Occluder

EXPERIMENTAL

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

Device: Closure of bronchopleural fistula with Occlutech Figulla

Interventions

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.

Also known as: Bronchoscopic bronchopleural fistula closure with occluders

Occluder

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 14 years old
• Bronchopleural fistulas

You may not qualify if:

• Clinical conditions increasing surgical risk (hemodynamic instability, respiratory distress)
• Immunosuppressed patients
• Acute intense inflammatory process in fistula edge
• Suppurative pleural cavity infection

Sponsors & Collaborators

• University of Sao Paulo: lead
• InCor Heart Institute: collaborator
• Occlutech International AB: collaborator

Study Sites (2)

Heart Institute (InCor) Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo

São Paulo, 05403-900, Brazil

Location

Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo

São Paulo, Brazil

Location

Related Publications (4)

• 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.

  PMID: 21896530 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.

  PMID: 21440188 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.

  PMID: 20011853 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.

  PMID: 28082466 RESULT

Study Officials

• Miguel L. Tedde, MD, PhD

  Heart Institute (InCor) HC of the Sao Paulo University School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: October 1, 2016
• Last Updated: May 25, 2017

Record last verified: 2017-05

Locations

BR (2)