Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device (TEFGoreHelex)

This study has been terminated.
(The study was terminated because the rate of prothesis dislocation was too high.)
Sponsor:
Collaborators:
InCor Heart Institute
W.L.Gore & Associates
Information provided by (Responsible Party):
Miguel L. Tedde, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01153061
First received: June 8, 2010
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 4
Study Start Date: June 2010
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153061

Locations
Brazil
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
Investigators
Principal Investigator: Miguel L Tedde, MD, PhD Heart Institute (InCor)-HC of the Sao Paulo University Medica School
  More Information

No publications provided

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
Study First Received: June 8, 2010
Last Updated: March 18, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Fistula
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

ClinicalTrials.gov processed this record on September 18, 2014