Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device

Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01153061

Acronym

TEFGoreHelex

Enrollment

Registered

2010-06-29

Start date

2010-06-30

Completion date

2012-12-31

Last updated

2013-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Tracheo-esophageal Fistula

Brief summary

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

Interventions

DEVICEFistula closure with Gore Helex Septal Occluder

The occluder will be released at the tracheoesophageal fistoulous traject through endoscopic procedures

DEVICEGore Helex Septal Occluder

Fistula closure with endoscopic release of occluder in the fistula traject.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026