Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-03-01 @ 10:08 AM
Study NCT ID:
NCT02392403
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2015-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Investigation of the Nucleus® CI532 Cochlear Implant
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': 'cjames@cochlear.com', 'phone': '+33 534 638 584', 'title': 'Chris James', 'organization': 'Cochlear'}, 'certainAgreement': {'otherDetails': 'The investigator agrees to send any Conference presentations/publications to the Sponsor for review at least 30 days prior to publication/presentation and after the first publication has been submitted. The Sponsor has the right to require any confidential information to be removed. If there is intellectual property disclosed, which the Sponsor intends to protect by registration such as by patent application, the Sponsor may require the release of the publication to be delayed by up to 120 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '16 months', 'eventGroups': [{'id': 'EG000', 'title': 'Nucleus CI532 Cochlear Implant', 'description': 'Single arm study. All participants received CI532.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 30, 'seriousNumAtRisk': 45, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders'}, {'term': 'Dizziness and/or vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'Prolonged hospitalization for re-implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Death due to myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Hospitalization for hysterectomy and bladder wall reinforcement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nucleus CI532 Cochlear Implant', 'description': 'Single arm study. All participants received CI532.'}], 'classes': [{'title': 'Completely in scala tympani', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Dislocation in scala vestibuli', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to one month post-surgery', 'description': 'The position of the electrode array can be completely in scala tympani, completely in scala vestibuli, or may transverse from scala tympani to scala vestibuli. The position can be determined from high resolution flat panel volume tomography (Cone beam) imaging.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient was explanted and reimplanted with a different type of device.'}, {'type': 'SECONDARY', 'title': 'Array Proximity to the Modiolus Measured Using the Wrapping Factor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nucleus CI532 Cochlear Implant', 'description': 'Single arm study. All participants received CI532.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'spread': '0.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to one month post-surgery', 'description': 'The ratio of the active array length and the corresponding lateral wall length', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surgeon Questionnaire on Implant Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nucleus CI532 Cochlear Implant', 'description': 'Single arm study. All participants received CI532.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at time of surgery', 'description': 'To collect experiences using the CI532. At each surgery, the surgeon was asked whether "overall the CI532 was easy to handle and the EA32 easy to insert". We counted the number of surgeons who strongly agreed or who agreed.', 'unitOfMeasure': 'Surgeons', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nucleus CI532 Cochlear Implant', 'description': 'Single arm study. All participants received CI532.'}], 'classes': [{'title': 'Quiet Implant Ear', 'categories': [{'measurements': [{'value': '52.500', 'groupId': 'OG000', 'lowerLimit': '25.0', 'upperLimit': '71.8'}]}]}, {'title': 'Quiet Best Aided', 'categories': [{'measurements': [{'value': '29.668', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '56.0'}]}]}, {'title': '10 db Signal-to-Noise Ratio (SNR) Implant Ear', 'categories': [{'measurements': [{'value': '63.725', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '88.2'}]}]}, {'title': '10 db Signal-to-Noise Ratio (SNR) Best Aided', 'categories': [{'measurements': [{'value': '33.690', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '63.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline and 6 months post activation', 'description': 'Change in percent correct speech recognition test scores for implant ear alone and best aided', 'unitOfMeasure': 'Percent correct', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nucleus CI532 Cochlear Implant', 'description': 'Single arm study. All participants received CI532.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000', 'lowerLimit': '21.577', 'upperLimit': '34.738'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post activation', 'description': 'The Glasgow Benefit Inventory is a single time point measure of patient reported benefit.\n\nA score of 0 indicates no benefit; the minimum score is -100 and the maximum is +100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nucleus CI532 Cochlear Implant', 'description': 'Single arm study. All participants received CI532.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.22', 'groupId': 'OG000', 'lowerLimit': '1.695', 'upperLimit': '2.750'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 months post activation', 'description': 'Rating scale. 0=worst; 10=best', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nucleus CI532 Cochlear Implant', 'description': 'Single arm study. All participants received CI532.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline and 6 months post activation', 'description': 'We report only the change for the 500 Hz frequency.', 'unitOfMeasure': 'Decibels', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Note that some patients had no measurable pre-operative hearing'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events at Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nucleus CI532 Cochlear Implant', 'description': 'Single arm study. All participants received CI532.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at time of surgery', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events Post Surgery to 6 Months Post-activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nucleus CI532 Cochlear Implant', 'description': 'Single arm study. All participants received CI532.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'post surgery to 6 months post-activation', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nucleus CI532 Cochlear Implant', 'description': 'Single arm study. All participants received CI532.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Nucleus CI532 Cochlear Implant', 'description': 'Single arm study. All participants received CI532.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'spread': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-26', 'studyFirstSubmitDate': '2015-03-13', 'resultsFirstSubmitDate': '2017-07-27', 'studyFirstSubmitQcDate': '2015-03-13', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-26', 'studyFirstPostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan', 'timeFrame': 'up to one month post-surgery', 'description': 'The position of the electrode array can be completely in scala tympani, completely in scala vestibuli, or may transverse from scala tympani to scala vestibuli. The position can be determined from high resolution flat panel volume tomography (Cone beam) imaging.'}], 'secondaryOutcomes': [{'measure': 'Array Proximity to the Modiolus Measured Using the Wrapping Factor', 'timeFrame': 'up to one month post-surgery', 'description': 'The ratio of the active array length and the corresponding lateral wall length'}, {'measure': 'Surgeon Questionnaire on Implant Surgery', 'timeFrame': 'at time of surgery', 'description': 'To collect experiences using the CI532. At each surgery, the surgeon was asked whether "overall the CI532 was easy to handle and the EA32 easy to insert". We counted the number of surgeons who strongly agreed or who agreed.'}, {'measure': 'Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months', 'timeFrame': 'baseline and 6 months post activation', 'description': 'Change in percent correct speech recognition test scores for implant ear alone and best aided'}, {'measure': 'Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire', 'timeFrame': '6 months post activation', 'description': 'The Glasgow Benefit Inventory is a single time point measure of patient reported benefit.\n\nA score of 0 indicates no benefit; the minimum score is -100 and the maximum is +100.'}, {'measure': 'Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months', 'timeFrame': 'baseline and 6 months post activation', 'description': 'Rating scale. 0=worst; 10=best'}, {'measure': 'Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months', 'timeFrame': 'baseline and 6 months post activation', 'description': 'We report only the change for the 500 Hz frequency.'}, {'measure': 'Number of Adverse Events at Surgery', 'timeFrame': 'at time of surgery'}, {'measure': 'Number of Adverse Events Post Surgery to 6 Months Post-activation', 'timeFrame': 'post surgery to 6 months post-activation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '30465637', 'type': 'DERIVED', 'citation': 'Hey M, Wesarg T, Mewes A, Helbig S, Hornung J, Lenarz T, Briggs R, Marx M, Ramos A, Stover T, Escude B, James CJ, Aschendorff A. Objective, audiological and quality of life measures with the CI532 slim modiolar electrode. Cochlear Implants Int. 2019 Mar;20(2):80-90. doi: 10.1080/14670100.2018.1544684. Epub 2018 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode design.\n\nNucleus® 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* Eighteen years of age or older at the time of implantation\n* Conventional candidate for cochlear implantation with a perimodiolar electrode array according to local criteria (excepting the exclusion criteria that follow)\n* Native speaker in the local language used to assess clinical performance\n\nExclusion Criteria:\n\n* Evidence of hearing loss prior to 5 years of age\n* Prior cochlear implantation; i.e. having a cochlear implant in the contralateral ear, or previously implanted in either ear\n* Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery\n* Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination\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 on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices\n* Unwillingness or inability of the candidate to comply with all investigational requirements such as undergoing a post-operative digital volume tomography/ConeBeam scan\n* Patients with existing Cerebral Spinal Fluid shunts or drains, existing perilymph fistula, skull fracture or Cerebral Spinal Fluid leak\n* Patients with recurrent episodes of bacterial meningitis\n* Pregnancy or breast-feeding\n* Known allergies to components of the implant\n* Wearing other active implants with known interference with cochlear implants'}, 'identificationModule': {'nctId': 'NCT02392403', 'briefTitle': 'Clinical Investigation of the Nucleus® CI532 Cochlear Implant', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cochlear'}, 'officialTitle': 'Clinical Investigation of the Nucleus® CI532 Cochlear Implant', 'orgStudyIdInfo': {'id': 'CLTD5446'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nucleus CI532 cochlear implant', 'interventionNames': ['Device: Nucleus CI532 cochlear implant']}], 'interventions': [{'name': 'Nucleus CI532 cochlear implant', 'type': 'DEVICE', 'armGroupLabels': ['Nucleus CI532 cochlear implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The HEARing CRC', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '31059', 'city': 'Toulouse', 'state': 'Midi-Pyrénées', 'country': 'France', 'facility': "Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan", 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Ear, Nose and Throat Department, University of Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Ear, Nose and Throat Department, Universitätsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Klinikum der J. W. Goethe-Universität Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Ear, Nose and Throat Department, Medizinische Hochschule', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein - Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '35016', 'city': 'Las Palmas', 'state': 'Gran Canaria', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario Insular Materno Infantil', 'geoPoint': {'lat': 28.58232, 'lon': -16.16555}}], 'overallOfficials': [{'name': 'Chris J James, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cochlear'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cochlear', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}