Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device (TEFGoreHelex)
|ClinicalTrials.gov Identifier: NCT01153061|
Recruitment Status : Terminated (The study was terminated because the rate of prothesis dislocation was too high.)
First Posted : June 29, 2010
Last Update Posted : March 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Acquired Tracheo-esophageal Fistula||Device: Fistula closure with Gore Helex Septal Occluder Device: Gore Helex Septal Occluder||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder|
|Study Start Date :||June 2010|
|Primary Completion Date :||July 2012|
|Study Completion Date :||December 2012|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|