Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device

Brief Title

Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device

Official Title

Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder

Brief Summary

      Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac
      septal defects.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder


Condition

Acquired Tracheo-esophageal Fistula

Intervention

Fistula closure with Gore Helex Septal Occluder

Study Arms / Comparison Groups

 Fistula closure with occluder
Description:  Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

4

Start Date

June 2010

Completion Date

December 2012

Primary Completion Date

July 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Patients over 14 years old

          -  Benign tracheoesophageal fistulas identified through bronchoscopy;

        Exclusion Criteria:

          -  Malign neoplasia

          -  Current mechanical ventilation

          -  Immunosuppressed

          -  Current local inflammatory process at fistulas borders

          -  Other clinical risk factors
      

Gender

All

Ages

14 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Miguel L Tedde, MD, PhD, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT01153061

Organization ID

USP-0201/10-TEF


Responsible Party

Principal Investigator

Study Sponsor

University of Sao Paulo

Collaborators

 InCor Heart Institute

Study Sponsor

Miguel L Tedde, MD, PhD, Principal Investigator, Heart Institute (InCor)-HC of the Sao Paulo University Medica School


Verification Date

March 2013