Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-27 @ 10:04 PM
Study NCT ID:
NCT01153061
Status:
TERMINATED
Last Update Posted:
2013-03-19
First Post:
2010-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055989', 'term': 'Septal Occluder Device'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'The study was terminated because the rate of prothesis dislocation was too high.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-18', 'studyFirstSubmitDate': '2010-06-08', 'studyFirstSubmitQcDate': '2010-06-28', 'lastUpdatePostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder', 'timeFrame': '6 months', '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.\n\nA thorax CT scan will ascertain correct positioning and stability of the occluder.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acquired Tracheo-esophageal Fistula']}, 'descriptionModule': {'briefSummary': 'Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac septal defects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 14 years old\n* Benign tracheoesophageal fistulas identified through bronchoscopy;\n\nExclusion Criteria:\n\n* Malign neoplasia\n* Current mechanical ventilation\n* Immunosuppressed\n* Current local inflammatory process at fistulas borders\n* Other clinical risk factors'}, 'identificationModule': {'nctId': 'NCT01153061', 'acronym': 'TEFGoreHelex', 'briefTitle': 'Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder', 'orgStudyIdInfo': {'id': 'USP-0201/10-TEF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fistula closure with occluder', 'description': 'Patients with benign tracheoesophageal fistulas will be submitted to the correction with the occluder.', 'interventionNames': ['Device: Fistula closure with Gore Helex Septal Occluder', 'Device: Gore Helex Septal Occluder']}], 'interventions': [{'name': 'Fistula closure with Gore Helex Septal Occluder', 'type': 'DEVICE', 'description': 'The occluder will be released at the tracheoesophageal fistoulous traject through endoscopic procedures', 'armGroupLabels': ['Fistula closure with occluder']}, {'name': 'Gore Helex Septal Occluder', 'type': 'DEVICE', 'description': 'Fistula closure with endoscopic release of occluder in the fistula traject.', 'armGroupLabels': ['Fistula closure with occluder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Miguel L Tedde, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Institute (InCor)-HC of the Sao Paulo University Medica School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'InCor Heart Institute', 'class': 'OTHER'}, {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Miguel L. Tedde', 'investigatorAffiliation': 'University of Sao Paulo'}}}}