Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT01287312
Status:
UNKNOWN
Last Update Posted:
2011-02-01
First Post:
2011-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014138', 'term': 'Tracheoesophageal Fistula'}], 'ancestors': [{'id': 'D004937', 'term': 'Esophageal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D016156', 'term': 'Respiratory Tract Fistula'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D014133', 'term': 'Tracheal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-01-31', 'studyFirstSubmitDate': '2011-01-27', 'studyFirstSubmitQcDate': '2011-01-31', 'lastUpdatePostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Closure of the fistula', 'description': 'Closure of the fistula'}], 'secondaryOutcomes': [{'measure': 'clinical and pulmonary improvment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['We will treat children age 1 month to 20 years with recurrent TEF after surgical failure'], 'conditions': ['Tracheo Esophageal Fistula']}, 'descriptionModule': {'briefSummary': 'Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure. Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported with a good results ( 4 cases). There were no serious advers effects.\n\nThe investigators want to use also TCA 50% for endoscopic repair in children with recurrent TEF.', 'detailedDescription': 'Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure. Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported with a good results ( 4 cases). There were no serious advers effects.\n\nWe want to use also TCA 50% for endoscopic repair in children with recurrent TEF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children age 1 month- 20 years old with recurrent TEF.\n* Failure of surgical repair.'}, 'identificationModule': {'nctId': 'NCT01287312', 'briefTitle': 'Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair', 'orgStudyIdInfo': {'id': 'shlomoco-HMO-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endoscopic repair of recurrent TEF by trichloroacetic acid aplications', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Hadas Lemberg, PhD', 'role': 'CONTACT', 'email': 'lhadas@hadassah.org.il', 'phone': '+972 2 6776095'}, {'name': 'Shlomo Cohen, DM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'shlomo cohen, MD', 'role': 'CONTACT', 'email': 'shlomoco@hadassah.org.il', 'phone': '+972 2 6776817'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Shlomo Cohen', 'oldOrganization': 'Hadassah Medical Organization'}}}}