Back to resultsEndoscopic Closure of Tracheoesophageal Fistulas With Occluder Device (TEFGoreHelex)
Primary Purpose
Acquired Tracheo-esophageal Fistula
Status
Terminated
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Fistula closure with Gore Helex Septal Occluder
Gore Helex Septal Occluder
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Tracheo-esophageal Fistula
Eligibility 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
Sites / Locations
- Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fistula closure with occluder
Arm Description
Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01153061
First Posted
June 8, 2010
Last Updated
March 18, 2013
Sponsor
University of Sao Paulo
Collaborators
InCor Heart Institute, W.L.Gore & Associates
1. Study Identification
Unique Protocol Identification Number
NCT01153061
Brief Title
Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device
Acronym
TEFGoreHelex
Official Title
Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated because the rate of prothesis dislocation was too high.
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
InCor Heart Institute, W.L.Gore & Associates
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac septal defects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Tracheo-esophageal Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fistula closure with occluder
Arm Type
Experimental
Arm Description
Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder.
Intervention Type
Device
Intervention Name(s)
Fistula closure with Gore Helex Septal Occluder
Intervention Description
The occluder will be released at the tracheoesophageal fistoulous traject through endoscopic procedures
Intervention Type
Device
Intervention Name(s)
Gore Helex Septal Occluder
Intervention Description
Fistula closure with endoscopic release of occluder in the fistula traject.
Primary Outcome Measure Information:
Title
Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel L Tedde, MD, PhD
Organizational Affiliation
Heart Institute (InCor)-HC of the Sao Paulo University Medica School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School
City
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device
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