Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-02 @ 4:54 PM
Study NCT ID:
NCT02677220
Status:
TERMINATED
Last Update Posted:
2019-03-12
First Post:
2016-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Implantation With the Nucleus CI532 Cochlear Implant in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'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': 'loneill@cochlear.com', 'phone': '3032647180', 'title': 'Director of Clinical Research', 'organization': 'Cochlear'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 months', 'description': 'SAE October 2016 - blood and pus draining from the incision. Antibiotics prescribed.\n\nNovember 2016 - resolved. Initial activation of the device. December 2016 through April 26, 2017 - continued drainage and treatment using a combination of routine wound care and oral antibiotics.\n\nJune 2017 - Explantation required July 2017 - Withdrawn - test device was no longer in place.', 'eventGroups': [{'id': 'EG000', 'title': 'Surgical', 'description': 'Subjects with the CI532 cochlear implant in one ear', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Device Explant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AzBio Sentence Recognition in Noise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgical', 'description': 'Subjects implanted with the CI532 cochlear implant in one ear'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months post-activation', 'description': "The AzBio Sentence test was recorded at 3 months prior to subject withdraw. Not collected at endpoint. AzBio Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct.", 'unitOfMeasure': 'percent correct', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glasgow Benefit Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgical', 'description': 'Subjects implanted with the CI532 cochlear implant in one ear'}], 'timeFrame': '6 months post-activation', 'description': 'The Glasgow Benefit Inventory (GBI) is a health utility assessment used at six months post-operatively. Performance benefits are a change in score from pre- to post-operatively, scored from -100 to +100.', 'reportingStatus': 'POSTED', 'populationDescription': 'subject did not reach endpoint - GBI was not collected at 3 months per protocol'}, {'type': 'SECONDARY', 'title': 'Speech, Spatial, and Qualities of Hearing Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Surgical', 'description': 'Subjects with the CI532 cochlear implant in one ear'}], 'timeFrame': '6 months post-activation', 'description': 'The Speech Spatial and Qualities of Hearing Scale (SSQ) is a subjective measure of satisfaction. Change is reflected in a gain in scores pre- to post-operatively (-10 to +10).', 'reportingStatus': 'POSTED', 'populationDescription': 'subject did not reach endpoint - SSQ was not collected at 3 months per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Surgical', 'description': 'Subjects implanted with the CI532 cochlear implant in one ear'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Surgical', 'description': 'Subjects implanted with the CI532 cochlear implant in one ear'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '63', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2016-04-16', 'size': 1099159, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-30T12:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'No enrolled subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-18', 'studyFirstSubmitDate': '2016-02-03', 'resultsFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2016-02-04', 'lastUpdatePostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-18', 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AzBio Sentence Recognition in Noise', 'timeFrame': '3 months post-activation', 'description': "The AzBio Sentence test was recorded at 3 months prior to subject withdraw. Not collected at endpoint. AzBio Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct."}], 'secondaryOutcomes': [{'measure': 'Glasgow Benefit Inventory', 'timeFrame': '6 months post-activation', 'description': 'The Glasgow Benefit Inventory (GBI) is a health utility assessment used at six months post-operatively. Performance benefits are a change in score from pre- to post-operatively, scored from -100 to +100.'}, {'measure': 'Speech, Spatial, and Qualities of Hearing Scale', 'timeFrame': '6 months post-activation', 'description': 'The Speech Spatial and Qualities of Hearing Scale (SSQ) is a subjective measure of satisfaction. Change is reflected in a gain in scores pre- to post-operatively (-10 to +10).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant.\n\nThe Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet current cochlear implant criteria at the implanting center\n* 18 years or older with bilateral sensorineural hearing loss\n* Limited benefit from appropriate binaural hearing aids\n* Moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high frequencies\n* Preoperative unaided threshold between 40 and 65 dB HL, inclusively, at 250 Hertz (Hz) and 500 Hz in the ear to be implanted\n* Fluent speaker in the language used to assess clinical performance\n\nExclusion Criteria:\n\n* Evidence of hearing loss prior to age 5\n* Sensorineural severe to profound hearing loss greater than 20 years at and above 2000Hz\n* Simultaneous bilateral implantation prior to the study\n* Medical or psychological conditions that contraindicate undergoing general anesthesia or surgery\n* Cochlear anomaly that might prevent complete insertion of the electrode array\n* Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve, or central auditory pathway\n* Active middle ear infection\n* Tympanic membrane perforation\n* Unrealistic expectations\n* Unwillingness or inability co comply with all investigational requirements\n* Patients with existing cerebral shunts or drains\n* Recurrent episodes of bacterial meningitis'}, 'identificationModule': {'nctId': 'NCT02677220', 'briefTitle': 'Implantation With the Nucleus CI532 Cochlear Implant in Adults', 'nctIdAliases': ['NCT02560987'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Cochlear'}, 'officialTitle': 'Implantation With the Nucleus CI532 Cochlear Implant in Adults', 'orgStudyIdInfo': {'id': 'CAM5631'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgical', 'description': 'Subjects to be implanted with the CI532 cochlear implant in one ear', 'interventionNames': ['Device: CI532 cochlear implant']}], 'interventions': [{'name': 'CI532 cochlear implant', 'type': 'DEVICE', 'armGroupLabels': ['Surgical']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cochlear', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'NYU Langone Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}