Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-03-06 @ 4:01 PM
Study NCT ID:
NCT02830659
Status:
UNKNOWN
Last Update Posted:
2016-07-13
First Post:
2016-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cochlear Implants Registry in Thailand Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-09', 'studyFirstSubmitDate': '2016-07-02', 'studyFirstSubmitQcDate': '2016-07-09', 'lastUpdatePostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aids Threshold 1', 'timeFrame': '1 year', 'description': 'The pure tone air-conduction threshold at 0.25, 0.5, 1, 2, 3, 4, 6, 8 kilohertz, measuring in the sound-proof room using the standard audiometry while patient is using cochlear implants.'}], 'secondaryOutcomes': [{'measure': 'CAP 1', 'timeFrame': '1 year', 'description': 'Categories of Auditory Performance (CAP) is an index consisting of eight performance categories, relating to auditory perception. It is arranged in a hierarchy of skills that increase in difficulty for example from the ability to perceive environmental sounds right up to using the telephone. It is widely used in the range of current research on children with cochlear implants and is an easy to use tool for monitoring progress.'}, {'measure': 'Quality of life', 'timeFrame': '5 years', 'description': 'The quality of life will be assessed by interviewing questionnaires using HUI-3.'}]}, 'conditionsModule': {'conditions': ['Cochlear Implantation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the outcome of cochlear implant including post operative hearing ability, developing of language, complication from cochlear implant, quality of life, and success factor of cochlear implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient who underwent surgery for cochlear implant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent surgery with cochlear implant\n\nExclusion Criteria:\n\n* Patients who reject to participate with this project'}, 'identificationModule': {'nctId': 'NCT02830659', 'acronym': 'CIRT', 'briefTitle': 'Cochlear Implants Registry in Thailand Project', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Cochlear Implants Registry in Thailand Project', 'orgStudyIdInfo': {'id': 'HE591146'}, 'secondaryIdInfos': [{'id': 'HSRI. 59-031', 'type': 'OTHER_GRANT', 'domain': 'Health System Research Institution'}, {'id': 'CERT004/59BRm', 'type': 'OTHER', 'domain': 'Central Research Ethics Committee'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10220', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'King Bhumibol Adulyadej Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10330', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'King Chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10400', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Otolaryngology Phramongkutklao College of Medicine', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10400', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Rajavithi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10400', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Ramathibodi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '26120', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Otolaryngology, Srinakharinwirot University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '40002', 'city': 'Khon Kaen', 'state': 'Changwat Khon Kaen', 'country': 'Thailand', 'facility': 'Srinagarind Hospital', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '90110', 'city': 'Songkhla', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Songkhlanagarind Hospital', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}, {'zip': '92000', 'city': 'Trang', 'state': 'Changwat Trang', 'country': 'Thailand', 'facility': 'Trang Hospital', 'geoPoint': {'lat': 7.55633, 'lon': 99.61141}}, {'zip': '50200', 'city': 'Chiang Mai', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Department of Otolaryngology, Faculty of Medicine, Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Thailand', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Neuro-otology unit', 'investigatorFullName': 'Kwanchanok Yimtae, M.D.', 'investigatorAffiliation': 'Khon Kaen University'}}}}