Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device
NCT ID: NCT01153061
Last Updated: 2013-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
4 participants
INTERVENTIONAL
2010-06-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fistula closure with occluder
Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder.
Fistula closure with Gore Helex Septal Occluder
The occluder will be released at the tracheoesophageal fistoulous traject through endoscopic procedures
Gore Helex Septal Occluder
Fistula closure with endoscopic release of occluder in the fistula traject.
Interventions
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Fistula closure with Gore Helex Septal Occluder
The occluder will be released at the tracheoesophageal fistoulous traject through endoscopic procedures
Gore Helex Septal Occluder
Fistula closure with endoscopic release of occluder in the fistula traject.
Eligibility Criteria
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Inclusion Criteria
* Benign tracheoesophageal fistulas identified through bronchoscopy;
Exclusion Criteria
* Current mechanical ventilation
* Immunosuppressed
* Current local inflammatory process at fistulas borders
* Other clinical risk factors
14 Years
ALL
No
Sponsors
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InCor Heart Institute
OTHER
W.L.Gore & Associates
INDUSTRY
University of Sao Paulo
OTHER
Responsible Party
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Miguel L. Tedde
MD, PhD
Principal Investigators
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Miguel L Tedde, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Heart Institute (InCor)-HC of the Sao Paulo University Medica School
Locations
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Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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USP-0201/10-TEF
Identifier Type: -
Identifier Source: org_study_id
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