Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-08 @ 3:35 AM
Study NCT ID:
NCT03904420
Status:
TERMINATED
Last Update Posted:
2020-10-29
First Post:
2019-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lchenier@cochlear.com', 'phone': '+14423254171', 'title': 'Laura Chenier', 'organization': 'Cochlear Limited'}, 'certainAgreement': {'otherDetails': 'The disclosure restriction on the PIs, no data was to be published prior to sponsor publishing. However, an agreement was in place with one site to provide presentation at upcoming conference for a poster presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Group A - New Model', 'description': 'Standardized programming and testing method\n\nClinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B - Traditional Model', 'description': 'Traditional clinical model which is not standardized across clinical sites\n\nTraditional Model: Standard clinical practice and education', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Time Spent With Audiologist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A - New Model', 'description': 'Standardized programming and testing method\n\nClinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches'}, {'id': 'OG001', 'title': 'Group B - Traditional Model', 'description': 'Traditional clinical model which is not standardized across clinical sites\n\nTraditional Model: Standard clinical practice and education'}], 'timeFrame': '6 months post activation', 'description': 'Change in the overall number of minutes of cochlear implant appointments over the first 6 months post activation in the new model (Group A) compared to the traditional model (Group B).', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects completed all required visits and data for primary endpoints were not collected due to study termination shortly after execution commenced.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A - New Model', 'description': 'Standardized programming and testing method\n\nClinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches'}, {'id': 'FG001', 'title': 'Group B - Traditional Model', 'description': 'Traditional clinical model which is not standardized across clinical sites\n\nTraditional Model: Standard clinical practice and education'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A - New Model', 'description': 'Standardized programming and testing method\n\nClinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches'}, {'id': 'BG001', 'title': 'Group B - Traditional Model', 'description': 'Traditional clinical model which is not standardized across clinical sites\n\nTraditional Model: Standard clinical practice and education'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-30', 'size': 4815197, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-04T06:05', 'hasProtocol': True}, {'date': '2019-04-25', 'size': 4283825, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-07T19:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'FDA determination of Fox software as class III medical device, not CDSS.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-07', 'studyFirstSubmitDate': '2019-04-03', 'resultsFirstSubmitDate': '2020-09-07', 'studyFirstSubmitQcDate': '2019-04-03', 'lastUpdatePostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-07', 'studyFirstPostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Time Spent With Audiologist', 'timeFrame': '6 months post activation', 'description': 'Change in the overall number of minutes of cochlear implant appointments over the first 6 months post activation in the new model (Group A) compared to the traditional model (Group B).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sensorineural Hearing Loss, Bilateral']}, 'descriptionModule': {'briefSummary': 'The clinical investigation is evaluating a new clinical model in a group of newly implanted subjects who have already been consented to CI surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are receiving a Nucleus® CI512, CI522, or CI532 electrodes\n* 18 years and older\n* Postlingual onset of hearing loss (onset of hearing loss \\>two years of age)\n* Individuals who qualify for cochlear implantation using the clinics current CI candidacy criteria\n* Individuals who have recently been implanted but not yet had their external device activated\n* Willingness to participate in a study and comply with all study requirements\n* Fluent in spoken English\n\nExclusion Criteria:\n\n* Ossification or any other cochlear anomaly that might prevent insertion of less than 10 electrodes of the electrode array\n* Diagnosis of retro-cochlear pathology\n* Diagnosis of auditory neuropathy\n* Subject considering an acoustic component in the implanted ear\n* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device\n* Unwillingness or inability to comply with all investigational requirements\n* Severe-profound sensorineural hearing loss \\>30 years\n* Previous cochlear implant in the contralateral ear. Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the investigator'}, 'identificationModule': {'nctId': 'NCT03904420', 'briefTitle': 'An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cochlear'}, 'officialTitle': 'An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients', 'orgStudyIdInfo': {'id': 'CAM5753'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A - New Model', 'description': 'Standardized programming and testing method', 'interventionNames': ['Other: Clinical Education and Treatment Model']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B - Traditional Model', 'description': 'Traditional clinical model which is not standardized across clinical sites', 'interventionNames': ['Other: Traditional Model']}], 'interventions': [{'name': 'Clinical Education and Treatment Model', 'type': 'OTHER', 'description': 'Patients will have self directed equipment education and standardized programming approaches', 'armGroupLabels': ['Group A - New Model']}, {'name': 'Traditional Model', 'type': 'OTHER', 'description': 'Standard clinical practice and education', 'armGroupLabels': ['Group B - Traditional Model']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76310', 'city': 'Wichita Falls', 'state': 'Texas', 'country': 'United States', 'facility': 'Head and Neck Surgical Associates', 'geoPoint': {'lat': 33.91371, 'lon': -98.49339}}, {'zip': '98026', 'city': 'Edmonds', 'state': 'Washington', 'country': 'United States', 'facility': 'Puget Sound ENT', 'geoPoint': {'lat': 47.81065, 'lon': -122.37736}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cochlear', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}