Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device

NCT01153061 — Phase 4, Terminated, 4 participants, University of Sao Paulo

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Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder

Registry	NCT01153061, acronym TEFGoreHelex
Status	Terminated - The study was terminated because the rate of prothesis dislocation was too high.
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	4 (Actual)
Sponsor	University of Sao Paulo (Other); collaborators: InCor Heart Institute, W.L.Gore & Associates
Conditions	Acquired Tracheo-esophageal Fistula
Interventions	Fistula closure with Gore Helex Septal Occluder, Gore Helex Septal Occluder (Device)
Dates	start 2010-06-01, primary completion 2012-07-01, completion 2012-12-01, first posted 2010-06-29, last updated 2013-03-19
Locations	1 site in Brazil

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Fistula closure with occluder	Experimental	Device: Fistula closure with Gore Helex Septal Occluder; Device: Gore Helex Septal Occluder	Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder.

Fistula closure with Gore Helex Septal Occluder (Device): The occluder will be released at the tracheoesophageal fistoulous traject through endoscopic procedures
Gore Helex Septal Occluder (Device): Fistula closure with endoscopic release of occluder in the fistula traject.

+Outcome measures

Primary outcomes

Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder [6 months]: The closure will be confirmed by endoscopic or bronchoscopic observation of the fistula at regular intervals: one week, two weeks, and four weeks after implant of the occluder. A thorax CT scan will ascertain correct positioning and stability of the occluder.

+Eligibility

Sex: All, ages: 14 Years to any

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

+Locations (1)

Facility	City	Country	Status
Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School	São Paulo, São Paulo	Brazil

+Investigators

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