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Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device (TEFGoreHelex)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01153061
Recruitment Status : Terminated (The study was terminated because the rate of prothesis dislocation was too high.)
First Posted : June 29, 2010
Last Update Posted : March 19, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac septal defects.

Condition or disease Intervention/treatment Phase
Acquired Tracheo-esophageal Fistula Device: Fistula closure with Gore Helex Septal Occluder Device: Gore Helex Septal Occluder Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder
Study Start Date : June 2010
Primary Completion Date : July 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Fistulas
U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. 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.

Eligibility Criteria

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153061

Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School
Sao Paulo, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo
InCor Heart Institute
W.L.Gore & Associates
Principal Investigator: Miguel L Tedde, MD, PhD Heart Institute (InCor)-HC of the Sao Paulo University Medica School
More Information

Responsible Party: Miguel L. Tedde, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01153061     History of Changes
Other Study ID Numbers: USP-0201/10-TEF
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Esophageal Fistula
Tracheoesophageal Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Respiratory Tract Fistula
Respiratory Tract Diseases
Tracheal Diseases