Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device

NCT01153061 | Terminated Phase 4 DMC

• 1 other identifier: USP-0201/10-TEF
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acquired Tracheo-esophageal Fistula

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Fistula closure with occluder

EXPERIMENTAL

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

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

Interventions

Fistula closure with Gore Helex Septal Occluder DEVICE

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

Fistula closure with occluder

Gore Helex Septal Occluder DEVICE

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

Fistula closure with occluder

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 14 years old
• Benign tracheoesophageal fistulas identified through bronchoscopy;

You may not qualify if:

• Malign neoplasia
• Current mechanical ventilation
• Immunosuppressed
• Current local inflammatory process at fistulas borders
• Other clinical risk factors

Sponsors & Collaborators

• University of Sao Paulo: lead
• InCor Heart Institute: collaborator
• W.L.Gore & Associates: collaborator

Study Sites (1)

Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Interventions

Septal Occluder Device

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Miguel L Tedde, MD, PhD

  Heart Institute (InCor)-HC of the Sao Paulo University Medica School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

BR (1)