Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device

Phase 4

Terminated

• Conditions: Acquired Tracheo-esophageal Fistula
• Interventions: Device: Fistula closure with Gore Helex Septal Occluder; Device: Gore Helex Septal Occluder

• Registration Number: NCT01153061
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Primary Completion: 2012-07
• Study Completion: 2012-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-18
• Last Update Posted: 2013-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fistula closure with occluder	Gore Helex Septal Occluder	Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder.
Fistula closure with occluder	Fistula closure with Gore Helex Septal Occluder	Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School; 🇧🇷 Sao Paulo, Brazil