Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device (TEFGoreHelex)
|Acquired Tracheo-esophageal Fistula||Device: Fistula closure with Gore Helex Septal Occluder Device: Gore Helex Septal Occluder||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder|
- Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder [ Time Frame: 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.
|Study Start Date:||June 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: Fistula closure with occluder
Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder.
Device: Fistula closure with Gore Helex Septal Occluder
The occluder will be released at the tracheoesophageal fistoulous traject through endoscopic proceduresDevice: Gore Helex Septal Occluder
Fistula closure with endoscopic release of occluder in the fistula traject.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153061
|Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School|
|Sao Paulo, Brazil, 05403-900|
|Principal Investigator:||Miguel L Tedde, MD, PhD||Heart Institute (InCor)-HC of the Sao Paulo University Medica School|