Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-27 @ 6:03 AM
Study NCT ID:
NCT02755935
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2016-04-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CI532 - Early Experience Study
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': 'ggrant@cochlear.com', 'phone': '410-375-0883', 'title': 'Ginger Grant, AuD', 'organization': 'Cochlear Americas'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Implanted', 'description': 'Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant\n\nCochlear Nucleus CI532: cochlear implantation', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 6, 'seriousNumAtRisk': 24, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Facial nerve', 'notes': 'Facial nerve weakness following surgery, Treated with oral medications and resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo or dizziness', 'notes': 'with stimulation of specific electrodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tingling sensation', 'notes': 'tingling/shocking with stimulation of specific electrodes. Programmed around, resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device related/programming problems', 'notes': 'open circuit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'death', 'notes': 'death from recurrence of a previous medical condition unrelated to the device or procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'skin flap', 'notes': 'Incision breakdown, revised successfully in the OR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted', 'description': 'Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant\n\nCochlear Nucleus CI532: cochlear implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'spread': '28.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postactivation of the sound processor', 'description': 'Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.', 'unitOfMeasure': 'percent correct', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'implanted and enrolled'}, {'type': 'PRIMARY', 'title': 'Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted', 'description': 'Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant\n\nCochlear Nucleus CI532: cochlear implantation'}], 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '24.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months post-activation', 'description': 'unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise', 'unitOfMeasure': 'percent correct', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'implanted and enrolled'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Implanted', 'description': 'Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant\n\nCochlear Nucleus CI532: cochlear implantation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Implanted', 'description': 'Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant\n\nCochlear Nucleus CI532: cochlear implantation'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', '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.'}, {'title': 'Speech understanding (% correct) on AzBio sentences in quiet in the ear to be implanted', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11.2', 'spread': '16.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent correct', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Speech understanding (% correct) on AzBio sentences in noise in the ear to be implanted', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '12.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent correct', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-31', 'size': 889232, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-12-13T14:24', 'hasProtocol': True}, {'date': '2018-01-23', 'size': 71106, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-01-23T14:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-20', 'studyFirstSubmitDate': '2016-04-19', 'resultsFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-23', 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear', 'timeFrame': '3 months postactivation of the sound processor', 'description': 'Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.'}, {'measure': 'Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear', 'timeFrame': '3 months post-activation', 'description': 'unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sensorineural Hearing Loss, Bilateral']}, 'descriptionModule': {'briefSummary': 'To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.', 'detailedDescription': 'To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical and audiological candidate for a CI532 cochlear implant per commercially approved, age appropriate, FDA indications\n* Post-linguistically deafened\n* Ability to complete age appropriate testing\n\nExclusion Criteria:\n\n* Previous cochlear implantation in the ear to be implanted\n* Pre-linguistically deafened (onset of hearing loss at less than two years of age)\n* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array\n* Diagnosis of retro-cochlear pathology\n* Diagnosis of auditory neuropathy\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* Additional cognitive handicaps that would prevent participation on all study requirements'}, 'identificationModule': {'nctId': 'NCT02755935', 'briefTitle': 'CI532 - Early Experience Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cochlear'}, 'officialTitle': 'Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study', 'orgStudyIdInfo': {'id': 'CAM5660'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Implanted', 'description': 'Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant', 'interventionNames': ['Device: Cochlear Nucleus CI532']}], 'interventions': [{'name': 'Cochlear Nucleus CI532', 'type': 'DEVICE', 'description': 'cochlear implantation', 'armGroupLabels': ['Implanted']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60201', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '48108', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'The University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Center for Hearing and Balance', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Ear Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cochlear', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}