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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Sao Paulo
Sponsor:
Collaborators:
InCor Heart Institute
Occlutech International AB
Information provided by (Responsible Party):
Miguel L. Tedde, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01153074
First received: June 28, 2010
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Bronchopleural Fistula
Device: Closure of bronchopleural fistula with Occlutech Figulla
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Closure of tracheobronchial fistulas with the Occlutech Figulla ASD N occluder [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 15
Study Start Date: June 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153074

Contacts
Contact: Miguel L. Tedde, MD, PhD 55-11 30695000 ext 5708 tedde@usp.br
Contact: Evelinda M Trindade, MD, PhD 55-11 30695935 evelinda.trindade@incor.usp.br

Locations
Brazil
Heart Institute (InCor) Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo Recruiting
Sao Paulo, Brazil, 05403-900
Contact: Evelinda M Trindade, MD, PhD    55 11 30695935    evelinda.trindade@incor.usp.br   
Principal Investigator: Miguel L Tedde, MD, PhD         
Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo Recruiting
Sao Paulo, Brazil
Contact: Paulo R Scordamaglio, MD    30696000 ext 7144    paulo.scorda@click21.com.br   
Sub-Investigator: Paulo R Scordamaglio, MD         
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
  More Information

Publications:
Responsible Party: Miguel L. Tedde, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01153074     History of Changes
Other Study ID Numbers: USP01089/09-TBF
Study First Received: June 28, 2010
Last Updated: March 18, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Bronchopleural fistula
Bronchoscopy

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 18, 2014