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

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ClinicalTrials.gov Identifier: NCT01153074
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : May 25, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Bronchopleural Fistula Device: Closure of bronchopleural fistula with Occlutech Figulla

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
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
Study Start Date : June 2010
Primary Completion Date : December 2015
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Occluder
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


Outcome Measures

Primary Outcome Measures :
  1. 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.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153074


Locations
Brazil
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
Sponsors and Collaborators
University of Sao Paulo
InCor Heart Institute
Occlutech International AB
Investigators
Principal Investigator: Miguel L. Tedde, MD, PhD Heart Institute (InCor) HC of the Sao Paulo University School