Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device (TEFGoreHelex)

University of Sao Paulo

Status and phase: Terminated; Phase 4

Conditions: Acquired Tracheo-esophageal Fistula

Treatments: Device: Fistula closure with Gore Helex Septal Occluder; Device: Gore Helex Septal Occluder

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01153061

USP-0201/10-TEF

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: All

Ages: 14+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Fistula closure with occluder

Experimental group

Description:

Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder.

Treatment:

Device: Fistula closure with Gore Helex Septal Occluder

Device: Gore Helex Septal Occluder