Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device

Acquired Tracheo-esophageal Fistula Clinical Trial

— TEFGoreHelex  

Official title:

Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01153061
• Other study ID #: USP-0201/10-TEF
• Status: Terminated
• Phase: Phase 4
• First received: June 8, 2010
• Last updated: March 18, 2013
• Start date: June 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Tracheo-esophageal Fistula
• Esophageal Fistula
• Fistula
• Tracheoesophageal Fistula

Intervention

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

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	InCor Heart Institute, W.L.Gore & Associates

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder	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.	6 months	Yes