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Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device

NCT01153061 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2013-03-19

No results posted yet for this study

Summary

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

Conditions

  • Acquired Tracheo-esophageal Fistula

Interventions

DEVICE

Fistula closure with Gore Helex Septal Occluder

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

DEVICE

Gore Helex Septal Occluder

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

Sponsors & Collaborators

  • InCor Heart Institute

    collaborator OTHER

  • W.L.Gore & Associates

    collaborator INDUSTRY

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Miguel L Tedde, MD, PhD · Heart Institute (InCor)-HC of the Sao Paulo University Medica School

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-07-31
Completion
2012-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01153061 on ClinicalTrials.gov