Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device (TEFGoreHelex)

March 18, 2013 updated by: Miguel L. Tedde, University of Sao Paulo

Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-900
        • Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fistula closure with occluder
Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

W.L.Gore & Associates
InCor Heart Institute

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

June 8, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (ESTIMATE)

June 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2013

Last Update Submitted That Met QC Criteria

March 18, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USP-0201/10-TEF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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