Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-02 @ 8:20 AM
Study NCT ID:
NCT02941627
Status:
COMPLETED
Last Update Posted:
2021-11-10
First Post:
2016-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D003638', 'term': 'Deafness'}, {'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': 'mhoe@oticonmedical.com', 'phone': '+33 4 93 95 18 18', 'title': 'Clinical Research Director', 'organization': 'Oticon Medical'}, 'certainAgreement': {'otherDetails': "No independent manuscript is submitted for publication until the multicentre manuscript is accepted for publication. PI can publish results from his/her own site after multicentre manuscript is accepted for publication or 18 months after study completion. Independent manuscript must be submitted to Sponsor for review at least 30 days prior to publication. Sponsor can request within the 30-day review period, PI shall delay proposed communication up to 60 days from the date of Sponsor's request.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "From the participant's cochlear implant surgery initiation to the end of month 12.", 'description': 'Safety Analysis was based on participants for whom the surgery for cochlear implantation was initiated. Among 53 patients enrolled: 1 died for heart stroke after the informed consent process, 1 was not implanted for surgical failure, and 1 for cholesteatoma discovered during surgical procedure. This patient was included in safety analysis as defined in the protocol. Then, among 53 patients enrolled 51 were evaluated for safety outcomes, 50 were successfully implanted and complete the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Neuro Zti/Neuro One Study Group', 'description': 'Neuro Zti: implant Neuro One: sound processor All patient will receive a Neuro Zti implant and fit with Neuro One sound processor.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 53, 'otherNumAffected': 15, 'seriousNumAtRisk': 51, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Post operative dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Post procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}], 'seriousEvents': [{'term': 'Diagnosis of Liver Cancer', 'notes': 'Hepatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Kidney failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}, {'term': 'Exacerbation of COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hearing In Noise Test Score in Quiet (HINT-Q) From Baseline to 6 Months in English-speaking Participants.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neuro Zti/Neuro One English-Speaking Participants - 6 Months', 'description': 'Neuro Zti: cochlear implant Neuro One: sound processor\n\nAll patients received a Neuro Zti implant and fitted with Neuro One sound processor'}], 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'spread': '33.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-operative, 6 Months', 'description': 'To assess the clinical efficiency, speech perception performance using the HINT sentences was measured in quiet at 6 months pos-activation in English speaking participants.\n\nPrimary clinical efficiency outcome is defined as the change in HINT scores from baseline to 6 months post-activation.\n\nRecorded HINT sentences lists were presented to the participant at 60 dB SPL (sound pressure level) pre-operatively in the best aided hearing conditions and at 6 months in the implanted ear after Neuro Zti implant activation. The post-activation assessment was performed in the implanted ear alone with masked controlateral ear. Resultant score is a percentage of words correctly repeated. Possible scores are range from 0% to 100% words correctly repeated. Change = (6 Months score - Baseline score). A score greater or equal to 10% was considered clinically significant improvement.', 'unitOfMeasure': 'percent change words correctly repeated', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical efficiency is reported on the thirty-three (33) English-speaking participants.'}, {'type': 'PRIMARY', 'title': 'Major Related Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}, {'units': 'number of adverse events', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neuro Zti/Neuro One Study Group', 'description': 'Neuro Zti: cochlear implant Neuro One: sound processor\n\nAll patients received a Neuro Zti implant and fitted with Neuro One sound processor.'}], 'classes': [{'title': 'Major device related AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}, {'units': 'number of adverse events', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Major trial procedure related AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}, {'units': 'number of adverse events', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Major unrelated AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}, {'units': 'number of adverse events', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': "Adverse event (AE) is defined as any undesired change from the participant's baseline condition symptom or clinically relevant symptom or disease, regardless of its cause.\n\nAEs include complications that are related to the device or clinical procedure, as well as unrelated AE that are not related to the device or the trial procedure.\n\nAEs were classified as Major if they corresponded to any of the following criteria:\n\n* life-threatening conditions (e.g. meningitis)\n* require hospitalization\n* result in permanent disability or damage (e.g. facial nerve paresis)\n* require revision surgery with or without explantation or re-implantation (e.g. device failure, flap necrosis)\n* medical events that could not be alleviated by electrode deactivation (e.g. tinnitus, facial nerve stimulation, pain)\n\nThe co-primary safety endpoint is the major related adverse events rate during the surgery and over the post-surgical period from activation to 12 months post-activation.", 'unitOfMeasure': 'number of major adverse events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of adverse events', 'denomUnitsSelected': 'number of adverse events', 'populationDescription': 'Safety is reported, on overall participants, in terms of surgical safety (intra-operative major complication rate) and post-surgical safety (major complication rate from the surgery to 12 months post activation to determine the long-term safety profile of the Neuro cochlear implant system).'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit on English-speaking Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Neuro Zti/Neuro One English-speaking Participants 3 Months', 'description': 'Neuro Zti: cochlear implant Neuro One: sound processor\n\nAll patients received a Neuro Zti implant and fitted with Neuro One sound processor\n\nClinical benefit is assessed in English-speaking participants at 3 months follow up.'}, {'id': 'OG001', 'title': 'Neuro Zti/Neuro One English-speaking Participants 6 Months', 'description': 'Neuro Zti: cochlear implant Neuro One: sound processor\n\nAll patients received a Neuro Zti implant and fitted with Neuro One sound processor\n\nClinical benefit is assessed in English-speaking participants at 6 months follow-up'}, {'id': 'OG002', 'title': 'Neuro Zti/Neuro One English-speaking Participants 12 Months', 'description': 'Neuro Zti: cochlear implant Neuro One: sound processor\n\nAll patients received a Neuro Zti implant and fitted with Neuro One sound processor\n\nClinical benefit is assessed in English-speaking participants at 12 months follow-up'}], 'classes': [{'title': 'HINT sentences in Quiet (60dB SPL)', 'categories': [{'title': 'Better (> 10 percent points)', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}, {'title': 'Similar (-10 to 10 percent points)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Worse (< -10 percent points)', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'HINT sentences in Noise (+10 dB SNR)', 'categories': [{'title': 'Better (> 10 percent points)', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}, {'title': 'Similar (-10 to 10 percent points)', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'Worse (< -10 percent points)', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3, 6 and 12 months', 'description': 'Clinical benefit is defined as the change of HINT scores post-operatively in the implanted ear only with masked contralateral ear and pre-operatively in the best aided conditions. Clinical benefit is measured in quiet and in noise using the Hearing in Noise Test (HINT).\n\nIn quiet, HINT sentences lists were presented to the participant at 60 decibel sound pressure level (dB SPL). In noise, the sentences were presented with concurrent background noise at +10 decibel signal-to-noise-ratio (dB SNR), signal level at 65 dB SPL and noise at 55 dB SPL. Resultant score is a percentage of words correctly repeated, possibly ranged from 0% to 100%.\n\nClinical benefit is computed for each participant. A positive difference of post- and pre-operative HINT scores is considered clinically significant if it exceeded 10 percentage points (pp). A decrease that exceeded 10 pp is considered a clinically significant decrement. A difference of less than 10 pp was considered as no change in performance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical benefit is reported on the English-speaking participants.'}, {'type': 'SECONDARY', 'title': 'Hearing In Noise Test Score in Quiet (HINT-Q) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neuro Zti/Neuro One English Speaking Participants', 'description': 'Neuro Zti: cochlear implant Neuro One: sound processor\n\nAll patients received a Neuro Zti implant and fitted with Neuro One sound processor'}], 'classes': [{'title': 'HINT-Q score at baseline in best aided conditions', 'categories': [{'measurements': [{'value': '13.3', 'spread': '16.0', 'groupId': 'OG000'}]}]}, {'title': 'HINT-Q score at 3 months in implanted ear', 'categories': [{'measurements': [{'value': '55.8', 'spread': '31.8', 'groupId': 'OG000'}]}]}, {'title': 'HINT-Q score at 6 months in implanted ear', 'categories': [{'measurements': [{'value': '64.8', 'spread': '27.2', 'groupId': 'OG000'}]}]}, {'title': 'HINT-Q score at 12 months in implanted ear', 'categories': [{'measurements': [{'value': '70.1', 'spread': '24.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-operative, 3, 6 and 12 Months', 'description': 'To assess the clinical efficiency, speech perception performance using the HINT sentences was measured in quiet pre-operatively, 3-, 6- and 12-months pos-activation on English speaking participants.\n\nSecondary clinical efficiency outcome is defined as the mean HINT scores from baseline to 12 months post-activation.\n\nRecorded HINT sentences lists were presented to the participant at 60 dB SPL pre-operatively in the best aided hearing conditions, at -, 6- and 12- months. The post-activation assessment was performed in the implanted ear alone with masked controlateral ear. Resultant score is a percentage of words correctly repeated. Possible scores are range from 0% to 100% words correctly repeated. A higher score is better.', 'unitOfMeasure': 'percentage of words correctly repeated', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical efficiency is reported on the thirty-three (33) English-speaking participants.'}, {'type': 'SECONDARY', 'title': 'Hearing In Noise Test Score in Noise (HINT-N) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neuro Zti/Neuro One English Speaking Participants', 'description': 'Neuro Zti: cochlear implant Neuro One: sound processor\n\nAll patients received a Neuro Zti implant and fitted with Neuro One sound processor'}], 'classes': [{'title': 'HINT-N score at baseline in best aided condition', 'categories': [{'measurements': [{'value': '13.3', 'spread': '17.7', 'groupId': 'OG000'}]}]}, {'title': 'HINT-N score at 3 months in implanted ear', 'categories': [{'measurements': [{'value': '43.8', 'spread': '30.6', 'groupId': 'OG000'}]}]}, {'title': 'HINT-N score at 6 months in implanted ear', 'categories': [{'measurements': [{'value': '52.3', 'spread': '30.0', 'groupId': 'OG000'}]}]}, {'title': 'HINT-N score at 12 months in implanted ear', 'categories': [{'measurements': [{'value': '57.6', 'spread': '29.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-operative, 3-, 6- and 12-Months', 'description': 'To assess the clinical efficiency, speech perception performance using the HINT sentences was measured in noise pre-operatively, 3-, 6- and 12-months pos-activation on English speaking participants.\n\nSecondary clinical efficiency outcome is defined as the mean HINT scores from baseline to 12 months post-activation.\n\nTesting open-set sentence recognition with concurrent background noise present at +10 decibel signal-to-ratio (dB SNR) with signal level presented at 65 dB SPL and noise at 55 dB SPL. Recorded HINT sentences lists were presented to the participant in front pre-operatively in the best aided condition and post-operatively in the implanted ear alone with masked contralateral ear. Speech and noise were colocated (S0N0). Resultant score is a percentage of words correct. Possible scores range from 0% to 100% words correctly repeated. A higher score is better.', 'unitOfMeasure': 'percentage of words correctly repeated', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical efficiency is reported on the thirty-three (33) English-speaking participants.'}, {'type': 'SECONDARY', 'title': 'Minor Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}, {'units': 'number of adverse events', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Participants', 'description': 'Neuro Zti: cochlear implant Neuro One: sound processor\n\nAll patients received a Neuro Zti implant and fitted with Neuro One sound processor'}], 'classes': [{'title': 'Device related AE', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Trial procedure related AE', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Unrelated AE', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': "Adverse event (AE) is defined as any undesired change from the participant's baseline condition symptom or clinically relevant symptom or disease, regardless of its cause.\n\nAEs include complications that are related to the device or clinical procedure, as well as unrelated AE that are not related to the device or the trial procedure.\n\nAEs were classified as Minor if they corresponded to any of the following criteria:\n\n* adverse event settled spontaneously without surgical procedure (e.g. hematoma)\n* adverse event settled spontaneously with conservative medical management\n\nThe secondary safety endpoint is the minor related adverse events rate during the surgery and over the post-surgical period from activation to 12 months post-activation.", 'unitOfMeasure': 'number of minor adverse events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of adverse events', 'denomUnitsSelected': 'number of adverse events', 'populationDescription': 'Safety is reported, on overall participants, in terms of surgical safety (intra-operative minor complication rate) and post-surgical safety (minor complication rate from the surgery to 12 months post activation to determine the long-term safety profile of the Neuro cochlear implant system).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Neuro Zti/Neuro One Study Group', 'description': 'All patient will receive a Neuro Zti implant and fit with Neuro One sound processor.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Among 53 patients enrolled: 1 passed away after the informed consent completion, 1 was not implanted for surgical failure, and 1 for cholesteatoma discovered during surgical procedure. This last patient was included in safety analysis as defined in the protocol. Therefore, among 53 patients enrolled 51 were evaluated for safety outcomes, and 50 were successfully implanted and complete the study.', 'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'Clinical Safety on Overall Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'Clinical Efficiency on English Speaking Participants', 'achievements': [{'comment': 'Among the 50 patients successfully implanted 33 English speaking participant complete speech performance measure.', 'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Surgical failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'cholesteatoma prevented implantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Efficacy outcomes will be based on English speaking participants, and safety on overall patients; English, French and Danish speaking participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Neuro Zti/Neuro One Study Group', 'description': 'Neuro Zti: cochlear implant Neuro One: sound processor\n\nAll patients will receive a Neuro Zti implant and fit with Neuro One sound processor'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '[18;40] years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '[40;50] years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '[50;60] years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '>=60 years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', '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': 'Age at implantation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '69.5', 'spread': '11.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Primary hearing loss etiology', 'classes': [{'title': 'Aging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Genetics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Noise exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': "Menière's disease", 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Otosclerosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Viral', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Implanted ear (side)', 'classes': [{'title': 'Left', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Right', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of hearing loss', 'classes': [{'title': 'Implanted ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30.7', 'spread': '19.0', 'groupId': 'BG000'}]}]}, {'title': 'Contralateral ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '33.2', 'spread': '19.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of hearing aid use', 'classes': [{'title': 'Implanted ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '22.2', 'spread': '15.8', 'groupId': 'BG000'}]}]}, {'title': 'Contralateral ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '22.6', 'spread': '15.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PTA (Pure Tone Average), 500 Hz to 2000 Hz', 'classes': [{'title': 'Implanted ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '101.3', 'spread': '13.3', 'groupId': 'BG000'}]}]}, {'title': 'Contralateral ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '95.8', 'spread': '16.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'dB HL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Fifty-one (51) participants with post-lingual severe-to-profound hearing loss took part in the study. One (1) subject could not be implanted because of the discovery during surgery of cholesteatoma (i.e., keratinized tissue growth in the middle ear or mastoid process) that was not detected before. The cochlear implantation was converted into choleastoma removal surgery.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-14', 'size': 2184168, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-18T09:34', 'hasProtocol': True}, {'date': '2020-01-27', 'size': 681160, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-18T09:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-13', 'studyFirstSubmitDate': '2016-10-18', 'resultsFirstSubmitDate': '2020-04-21', 'studyFirstSubmitQcDate': '2016-10-19', 'lastUpdatePostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-13', 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hearing In Noise Test Score in Quiet (HINT-Q) From Baseline to 6 Months in English-speaking Participants.', 'timeFrame': 'pre-operative, 6 Months', 'description': 'To assess the clinical efficiency, speech perception performance using the HINT sentences was measured in quiet at 6 months pos-activation in English speaking participants.\n\nPrimary clinical efficiency outcome is defined as the change in HINT scores from baseline to 6 months post-activation.\n\nRecorded HINT sentences lists were presented to the participant at 60 dB SPL (sound pressure level) pre-operatively in the best aided hearing conditions and at 6 months in the implanted ear after Neuro Zti implant activation. The post-activation assessment was performed in the implanted ear alone with masked controlateral ear. Resultant score is a percentage of words correctly repeated. Possible scores are range from 0% to 100% words correctly repeated. Change = (6 Months score - Baseline score). A score greater or equal to 10% was considered clinically significant improvement.'}, {'measure': 'Major Related Adverse Event (AE)', 'timeFrame': '12 months', 'description': "Adverse event (AE) is defined as any undesired change from the participant's baseline condition symptom or clinically relevant symptom or disease, regardless of its cause.\n\nAEs include complications that are related to the device or clinical procedure, as well as unrelated AE that are not related to the device or the trial procedure.\n\nAEs were classified as Major if they corresponded to any of the following criteria:\n\n* life-threatening conditions (e.g. meningitis)\n* require hospitalization\n* result in permanent disability or damage (e.g. facial nerve paresis)\n* require revision surgery with or without explantation or re-implantation (e.g. device failure, flap necrosis)\n* medical events that could not be alleviated by electrode deactivation (e.g. tinnitus, facial nerve stimulation, pain)\n\nThe co-primary safety endpoint is the major related adverse events rate during the surgery and over the post-surgical period from activation to 12 months post-activation."}], 'secondaryOutcomes': [{'measure': 'Clinical Benefit on English-speaking Participants', 'timeFrame': '3, 6 and 12 months', 'description': 'Clinical benefit is defined as the change of HINT scores post-operatively in the implanted ear only with masked contralateral ear and pre-operatively in the best aided conditions. Clinical benefit is measured in quiet and in noise using the Hearing in Noise Test (HINT).\n\nIn quiet, HINT sentences lists were presented to the participant at 60 decibel sound pressure level (dB SPL). In noise, the sentences were presented with concurrent background noise at +10 decibel signal-to-noise-ratio (dB SNR), signal level at 65 dB SPL and noise at 55 dB SPL. Resultant score is a percentage of words correctly repeated, possibly ranged from 0% to 100%.\n\nClinical benefit is computed for each participant. A positive difference of post- and pre-operative HINT scores is considered clinically significant if it exceeded 10 percentage points (pp). A decrease that exceeded 10 pp is considered a clinically significant decrement. A difference of less than 10 pp was considered as no change in performance.'}, {'measure': 'Hearing In Noise Test Score in Quiet (HINT-Q) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants', 'timeFrame': 'pre-operative, 3, 6 and 12 Months', 'description': 'To assess the clinical efficiency, speech perception performance using the HINT sentences was measured in quiet pre-operatively, 3-, 6- and 12-months pos-activation on English speaking participants.\n\nSecondary clinical efficiency outcome is defined as the mean HINT scores from baseline to 12 months post-activation.\n\nRecorded HINT sentences lists were presented to the participant at 60 dB SPL pre-operatively in the best aided hearing conditions, at -, 6- and 12- months. The post-activation assessment was performed in the implanted ear alone with masked controlateral ear. Resultant score is a percentage of words correctly repeated. Possible scores are range from 0% to 100% words correctly repeated. A higher score is better.'}, {'measure': 'Hearing In Noise Test Score in Noise (HINT-N) Pre-operatively, at 3-, 6- and 12-Months on English-speaking Participants', 'timeFrame': 'pre-operative, 3-, 6- and 12-Months', 'description': 'To assess the clinical efficiency, speech perception performance using the HINT sentences was measured in noise pre-operatively, 3-, 6- and 12-months pos-activation on English speaking participants.\n\nSecondary clinical efficiency outcome is defined as the mean HINT scores from baseline to 12 months post-activation.\n\nTesting open-set sentence recognition with concurrent background noise present at +10 decibel signal-to-ratio (dB SNR) with signal level presented at 65 dB SPL and noise at 55 dB SPL. Recorded HINT sentences lists were presented to the participant in front pre-operatively in the best aided condition and post-operatively in the implanted ear alone with masked contralateral ear. Speech and noise were colocated (S0N0). Resultant score is a percentage of words correct. Possible scores range from 0% to 100% words correctly repeated. A higher score is better.'}, {'measure': 'Minor Adverse Events (AE)', 'timeFrame': '12 months', 'description': "Adverse event (AE) is defined as any undesired change from the participant's baseline condition symptom or clinically relevant symptom or disease, regardless of its cause.\n\nAEs include complications that are related to the device or clinical procedure, as well as unrelated AE that are not related to the device or the trial procedure.\n\nAEs were classified as Minor if they corresponded to any of the following criteria:\n\n* adverse event settled spontaneously without surgical procedure (e.g. hematoma)\n* adverse event settled spontaneously with conservative medical management\n\nThe secondary safety endpoint is the minor related adverse events rate during the surgery and over the post-surgical period from activation to 12 months post-activation."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hearing Loss', 'Cochlear Implant surgery', 'Otorhinolaryngology', 'Oticon Medical', 'Neuro Cochlear Implant System'], 'conditions': ['Hearing Loss, Sensorineural', 'Hearing Loss, Cochlear', 'Deafness']}, 'referencesModule': {'references': [{'pmid': '32885711', 'type': 'RESULT', 'citation': 'Schramm D, Chen J, Morris DP, Shoman N, Philippon D, Caye-Thomasen P, Hoen M, Karoui C, Laplante-Levesque A, Gnansia D. Clinical efficiency and safety of the oticon medical neuro cochlear implant system: a multicenter prospective longitudinal study. Expert Rev Med Devices. 2020 Sep;17(9):959-967. doi: 10.1080/17434440.2020.1814741. Epub 2020 Oct 3.'}], 'seeAlsoLinks': [{'url': 'https://www.oticonmedical.com', 'label': 'oticon medical website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the efficacy and the safety profile of the Neuro Cochlear Implant System (CIS) in adults with severe-to-profound hearing loss.', 'detailedDescription': 'Appropriate adult cochlear implant candidates with sensorineural hearing loss, from English French Canadian centres and Danish centre, received Neuro Zti cochlear implant and fit with Neuro One sound processor.\n\nSpeech perception testing, using HINT (Hearing In Noise Test) sentences in quiet (65 dB SPL) (decibel, Sound Pressure Level) and in noise (+10 dB SNR) (decibel, Signal-to-Noise-Ratio), will be administrated pre-operatively in the best listening conditions and 3, 6, and 12 months post-activation in the implanted ear.\n\nAdverse events will be collected during the surgery and over the post-surgical period from activation to12 months post-activation.\n\nSafety will be assessed on the overall English, French and Danish participants. Efficacy will be assessed on English speaking participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Adults, eighteen (18) years of age or older.\n* Bilateral severe-to-profound sensorineural hearing loss, defined by pure-tone average (PTA) ≥70 dB HL (Hearing Level) at 500, 1000 and 2000 Hz on both ears.\n* HINT sentences recognition scores in quiet ≤ 50% correct, in the best-aided listening condition.\n* Post-lingual onset of deafness.\n* Primary implantation (no re-implantation).\n* Up-to-date pneumococcal vaccine.\n\nExclusion criteria\n\n* Medical conditions that contraindicate undergoing cochlear implant surgery (middle ear diseases i.e. AOM/CSOM (Acute Otitis Media/Chronic Suppurative Otitis Media) , lesions of auditory nerve, pathologies of central auditory pathway, otosclerosis; cochlear malformation i.e. Mondini malformation, cochlear ossification, large vestibular aqueduct).\n* Unrealistic expectations regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and medical device.\n* Unwillingness or inability of the candidate to comply with all investigational requirements.'}, 'identificationModule': {'nctId': 'NCT02941627', 'briefTitle': 'The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oticon Medical'}, 'officialTitle': 'The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults', 'orgStudyIdInfo': {'id': 'PIC_07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neuro Cochlear Implant System study group', 'description': 'All patients will receive a Neuro Zti implant and fitted with Neuro One sound processor', 'interventionNames': ['Device: Neuro Zti', 'Device: Neuro One']}], 'interventions': [{'name': 'Neuro Zti', 'type': 'DEVICE', 'description': 'Cochlear implant', 'armGroupLabels': ['Neuro Cochlear Implant System study group']}, {'name': 'Neuro One', 'type': 'DEVICE', 'description': 'Sound processor', 'armGroupLabels': ['Neuro Cochlear Implant System study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Halifax', 'country': 'Canada', 'facility': 'Nova Scotia Hearing and Speech centres', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Ottawa', 'country': 'Canada', 'facility': 'Ottawa Civic Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Québec', 'country': 'Canada', 'facility': 'CHU de Quebec - Université de Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Saskatoon', 'country': 'Canada', 'facility': 'Royal University Hospital', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'city': 'Toronto', 'country': 'Canada', 'facility': 'Sunnybrook Hopital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Gentofte Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'David Schramm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Civic Hospital'}, {'name': 'Daniel Philippon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Quebec'}, {'name': 'Joseph Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Hospital -Toronto'}, {'name': 'Nael Shoman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal University Hospital, Saskatoon'}, {'name': 'David P. Morris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Scotia Hearing and Speech Centres - Halifax'}, {'name': 'Per Cayé Thomasen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gentofte Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The present clinical trial started enrolling in Feb. 2017, therefore it does not contain a data sharing statement or Individual Participant Data sharing statement. Data will be analyzed as patient group data and submitted for peer-reviewed publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oticon Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}