Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device (TEFGoreHelex)
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|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|
|Actual Primary Completion Date :||July 2012|
|Actual 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 procedures
Device: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|