Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-04 @ 4:01 AM
Study NCT ID:
NCT02671032
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2016-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CHANGE Feasibility Study
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': 'bpickering@cochlear.com', 'phone': '+61296115909', 'title': 'Bernadette Pickering', 'organization': 'Cochlear'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months and 30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Implantation With Nucleus CI532 Cochlear Implant', 'description': 'All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.\n\nNucleus CI532 cochlear implant', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Discomfort/Pain of Pinna and Behind', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Onset of tinnitus in right ear', 'notes': 'Possibly related to procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Two events possibly related to procedure and/or device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drop in hearing', 'notes': 'Possibly related to procedure and/or device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'notes': 'Possibly related to procedure and/or device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold-like symptoms including sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'One event possibly related to procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Jaw ache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Incision site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Incision site tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis Externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abscess in left breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Polymyalgia Rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arm infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cactus injury to wrist', 'notes': 'Not related to procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip pain left and right sides', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in body joints', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sun spot removal (actinic keratosis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Report on Degree of Hearing as Measured by Pure Tone Audiogram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implantation With Nucleus CI532 Cochlear Implant', 'description': 'All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.\n\nNucleus CI532 cochlear implant'}], 'classes': [{'title': '6 months, 250 Hz : Function <= 70 dB HL', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '6 months, 250 Hz : Preserved 70 > dB HL <= 90', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '6 months, 250 Hz : Preserved > 90 dB HL', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '6 months, 500 Hz : Function <= 70 dB HL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6 months, 500 Hz : Preserved 70 > dB HL <= 90', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '6 months, 500 Hz : Preserved > 90 dB HL', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '6months, 750 Hz : Function <= 70 dB HL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6months, 750 Hz : Preserved 70 > dB HL <= 90', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '6months, 750 Hz : Preserved > 90 dB HL', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '12 months - 250 Hz : Function <= 70 dB HL', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '12 months - 250 Hz : Preserved 70 > dB HL <= 90', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': '12 months - 250 Hz : Preserved > 90 dB HL', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '12 months - 500 Hz : Function <= 70 dB HL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '12 months - 500 Hz : Preserved 70 > dB HL <= 90', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '12 months - 500 Hz : Preserved > 90 dB HL', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': '12 months - 750 Hz : Function <= 70 dB HL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '12 months - 750 Hz : Preserved 70 > dB HL <= 90', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '12 months - 750 Hz : Preserved > 90 dB HL', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months post activation', 'description': 'unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Report on Clinical Performance in Quiet and Noise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implantation With Nucleus CI532 Cochlear Implant', 'description': 'All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.\n\nNucleus CI532 cochlear implant'}], 'classes': [{'title': 'Quiet baseline, untreated ear', 'categories': [{'measurements': [{'value': '22', 'spread': '15.4', 'groupId': 'OG000'}]}]}, {'title': 'Baseline quiet, treated ear', 'categories': [{'measurements': [{'value': '10.4', 'spread': '8.7', 'groupId': 'OG000'}]}]}, {'title': 'Quiet, electronic alone 3 months', 'categories': [{'measurements': [{'value': '29.9', 'spread': '7.9', 'groupId': 'OG000'}]}]}, {'title': 'Quiet, electronic alone 6 months', 'categories': [{'measurements': [{'value': '31.9', 'spread': '8.7', 'groupId': 'OG000'}]}]}, {'title': 'Quiet, electronic alone 12 months', 'categories': [{'measurements': [{'value': '32.8', 'spread': '7.8', 'groupId': 'OG000'}]}]}, {'title': 'Quiet, hybrid hearing 3 months', 'categories': [{'measurements': [{'value': '27.4', 'spread': '9.7', 'groupId': 'OG000'}]}]}, {'title': 'Quiet, hybrid hearing 6 months', 'categories': [{'measurements': [{'value': '27.0', 'spread': '11.6', 'groupId': 'OG000'}]}]}, {'title': 'Quiet, hybrid hearing 12 months', 'categories': [{'measurements': [{'value': '25.3', 'spread': '8.1', 'groupId': 'OG000'}]}]}, {'title': 'Noise baseline, untreated ear', 'categories': [{'measurements': [{'value': '48.2', 'spread': '36.8', 'groupId': 'OG000'}]}]}, {'title': 'Noise baseline, treated ear', 'categories': [{'measurements': [{'value': '25.2', 'spread': '28.3', 'groupId': 'OG000'}]}]}, {'title': 'Noise, electric alone 3 months', 'categories': [{'measurements': [{'value': '81.7', 'spread': '17.2', 'groupId': 'OG000'}]}]}, {'title': 'Noise, electric alone 6 months', 'categories': [{'measurements': [{'value': '80.8', 'spread': '23.2', 'groupId': 'OG000'}]}]}, {'title': 'Noise, electric alone 12 months', 'categories': [{'measurements': [{'value': '85.1', 'spread': '14.8', 'groupId': 'OG000'}]}]}, {'title': 'Noise, hydrid hearing 3 months', 'categories': [{'measurements': [{'value': '77.5', 'spread': '18.8', 'groupId': 'OG000'}]}]}, {'title': 'Noise, hybrid hearing 6 months', 'categories': [{'measurements': [{'value': '72.0', 'spread': '29.3', 'groupId': 'OG000'}]}]}, {'title': 'Noise, hybrid hearing 12 months', 'categories': [{'measurements': [{'value': '83.7', 'spread': '10.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months, 6 months and 12 months post activation', 'description': 'Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB).', 'unitOfMeasure': 'percentage of correct words', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Report of Medical/Surgical and Device Related Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implantation With Nucleus CI532 Cochlear Implant', 'description': 'All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.\n\nNucleus CI532 cochlear implant'}], 'classes': [{'title': 'Possibly procedure related - pinna/behind pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Possibly procedure related - dizziness', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Possibly procedure related - drop in hearing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Possibly procedure related - nausea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Possibly procedure related - right ear tinnitus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Procedure related - headache', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Procedure related - incision site pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Procedure related - incision site tenderness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Procedure related - jaw ache', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Procedure related - initial insertion tip foldover', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Possibly device related - pinna/behind pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Possibly device related - dizziness', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Possibly device related - drop in hearing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Possibly device related - nausea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Device related - initial insertion top foldover', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months post activation.', 'description': 'Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness.', 'unitOfMeasure': 'Adverse Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implantation With Nucleus CI532 Cochlear Implant', 'description': 'All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.\n\nNucleus CI532 cochlear implant'}], 'classes': [{'title': 'Baseline - Speech Hearing', 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Baseline - Spatial Hearing', 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Baseline - Qualities of Hearing', 'categories': [{'measurements': [{'value': '4.7', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Baseline - Overall SSQ', 'categories': [{'measurements': [{'value': '4.3', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': '6 Month - Speech Hearing', 'categories': [{'measurements': [{'value': '5.9', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': '6 Month - Spatial Hearing', 'categories': [{'measurements': [{'value': '5.4', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': '6 Month - Qualities of Hearing', 'categories': [{'measurements': [{'value': '6.5', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': '6 Month - Overall SSQ', 'categories': [{'measurements': [{'value': '6.0', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Preoperative and 6 months post activation', 'description': 'Effect of intervention (implantation with CI532 cochlear implant) will be assessed by the change in SSQ scores from preoperative to 6 months post activation, where scores follow a system of 0 = not at all and 10 = perfectly in response to questions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glasgow Benefit Inventory (GBI).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implantation With Nucleus CI532 Cochlear Implant', 'description': 'All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.\n\nNucleus CI532 cochlear implant'}], 'classes': [{'title': 'General Benefit', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Social Benefit', 'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Physical Benefit', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Average Benefit', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post activation', 'description': 'Effect of intervention (implantation with CI532 cochlear implant) will be assessed at 6 months post activation with the Glasgow Benefit Inventory (GBI). Glasgow Benefit Inventory (GBI) is a measure of patient reported benefit developed especially for otorhinolaryngological interventions where scores range from -100 to 100, where a higher score corresponds to a better benefit outcome and a negative score value corresponds to a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Implantation With Nucleus CI532 Cochlear Implant', 'description': 'All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.\n\nNucleus CI532 cochlear implant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Implantation With Nucleus CI532 Cochlear Implant', 'description': 'All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.\n\nNucleus CI532 cochlear implant'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', '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': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Average Initial Age of Hearing Aid Fitted', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '59'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Onset of Initial Hearing Loss', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '48'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Severe Hearing Loss', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Severe hearing loss is classified as hearing loss of 66-90 dB', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-31', 'size': 762735, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-04T05:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2016-01-27', 'resultsFirstSubmitDate': '2020-09-07', 'studyFirstSubmitQcDate': '2016-01-28', 'lastUpdatePostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-19', 'studyFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Report on Degree of Hearing as Measured by Pure Tone Audiogram', 'timeFrame': '6 months and 12 months post activation', 'description': 'unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.'}, {'measure': 'Report on Clinical Performance in Quiet and Noise', 'timeFrame': '3 months, 6 months and 12 months post activation', 'description': 'Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB).'}, {'measure': 'Report of Medical/Surgical and Device Related Adverse Events.', 'timeFrame': '12 months post activation.', 'description': 'Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness.'}], 'secondaryOutcomes': [{'measure': 'Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)', 'timeFrame': 'Preoperative and 6 months post activation', 'description': 'Effect of intervention (implantation with CI532 cochlear implant) will be assessed by the change in SSQ scores from preoperative to 6 months post activation, where scores follow a system of 0 = not at all and 10 = perfectly in response to questions.'}, {'measure': 'Glasgow Benefit Inventory (GBI).', 'timeFrame': '6 months post activation', 'description': 'Effect of intervention (implantation with CI532 cochlear implant) will be assessed at 6 months post activation with the Glasgow Benefit Inventory (GBI). Glasgow Benefit Inventory (GBI) is a measure of patient reported benefit developed especially for otorhinolaryngological interventions where scores range from -100 to 100, where a higher score corresponds to a better benefit outcome and a negative score value corresponds to a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cochlear Prosthesis Implantation'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of the feasibility study is to examine audiological outcomes (audiometry and speech perception) and safety (adverse events and adverse device effects) with the Nucleus CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for cochlear implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Meet current cochlear implant indications at the implanting centre\n2. In addition to meeting current cochlear implant indications, subjects must also possess preoperative unaided hearing thresholds between 40 to 65 dB HL at 250 \\& 500Hz in the ear to be implanted.\n3. Fluent speaker in the local language used to assess clinical performance\n4. Eighteen years of age or older at the time of implantation with no upper age limit\n\nExclusion Criteria:\n\n1. Evidence of hearing loss prior to 5 years of age.\n2. Sensorineural severe-to-profound hearing loss greater than 20 years at 2 kHz and above.\n3. Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted.\n4. Additional disabilities that may affect the subject's participation or safety during the clinical investigation.\n5. Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.\n6. 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.\n7. Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway.\n8. Active middle-ear infection,\n9. Tympanic membrane perforation\n10. 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\n11. Unwillingness or inability of the candidate to comply with all investigational requirements.\n12. Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak.\n13. Patients with recurrent episodes of bacterial meningitis."}, 'identificationModule': {'nctId': 'NCT02671032', 'acronym': 'CLTD5626', 'briefTitle': 'CHANGE Feasibility Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cochlear'}, 'officialTitle': 'Characterisation of Audiological Outcomes With the Nucleus CI532 Cochlear Implant in Adult Subjects.', 'orgStudyIdInfo': {'id': 'CLTD5626'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Implantation with Nucleus CI532 cochlear implant', 'description': 'All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.', 'interventionNames': ['Device: Nucleus CI532 cochlear implant']}], 'interventions': [{'name': 'Nucleus CI532 cochlear implant', 'type': 'DEVICE', 'armGroupLabels': ['Implantation with Nucleus CI532 cochlear implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3053', 'city': 'Carlton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Hearing Cooperative Research Centre', 'geoPoint': {'lat': -37.8, 'lon': 144.96667}}, {'zip': '30002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Victorian Eye and Ear Hospital', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}], 'overallOfficials': [{'name': 'Robert Cowan, DipAud PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HEARing CRC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Cochlear do not have an approved platform for sharing IPD. Data may be provided to individual researchers on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cochlear', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Hearing Cooperative Research Centre', 'class': 'OTHER'}, {'name': 'Royal Victoria Eye and Ear Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}