Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-28 @ 5:47 AM
Study NCT ID:
NCT04271761
Status:
COMPLETED
Last Update Posted:
2021-07-16
First Post:
2020-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients
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': 'REnglish@cochlear.com', 'phone': '0386633105', 'title': 'Ruth English', 'phoneExt': '3105', 'organization': 'Cochlear'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'There were no adverse events reported in this study. The study was a single visit and adverse events only needed to be reported from time of enrolment to completion for each subject (ie a single day).', 'eventGroups': [{'id': 'EG000', 'title': 'Current Adult Recipients of Cochlear Carina System', 'description': 'Adults who are current recipients of the Cochlear Carina System. Participants will attend one scheduled visit where several acoustic measurements will be taken that do not require active participation by the participant.\n\nNon-interventional, post-market, pilot study of Carina Cochlear System: Several objective acoustic measurements will be performed that do not require active participation from the subject.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acoustic Sensitivity of Implanted Carina Microphone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Current Adult Recipients of Cochlear Carina System', 'description': 'Adults who are current recipients of the Cochlear Carina System. Participants will attend one scheduled visit where several acoustic measurements will be taken that do not require active participation by the participant.\n\nNon-interventional, post-market, pilot study of Carina Cochlear System: Several objective acoustic measurements will be performed that do not require active participation from the subject.'}], 'classes': [{'categories': [{'measurements': [{'value': '-64', 'groupId': 'OG000', 'lowerLimit': '-95', 'upperLimit': '-53'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from date of enrolment through to study visit, an average of 1 month', 'description': 'The acoustic sensitivity of the implanted microphone was measured using a white noise acoustic test signal was presented from a loudspeaker, with the sound pressure level monitored with an external probe microphone positioned over the location of the implanted microphone and the signal level at the implanted microphone recorded through a wireless link to the Carina implant.', 'unitOfMeasure': 'dB', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ratio of Response of Carina Microphone : Accelerometer for Acoustic Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Current Adult Recipients of Cochlear Carina System', 'description': 'Adults who are current recipients of the Cochlear Carina System. Participants will attend one scheduled visit where several acoustic measurements will be taken that do not require active participation by the participant.\n\nNon-interventional, post-market, pilot study of Carina Cochlear System: Several objective acoustic measurements will be performed that do not require active participation from the subject.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '-10.8', 'upperLimit': '22.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from date of enrolment through to study visit, an average of 1 month', 'description': 'Ratio \\[dB\\] of response of implanted microphone to response of implanted accelerometer, in-situ, for audiometric frequencies 250-6000 Hz, median and percentiles', 'unitOfMeasure': 'MAR (Microphone : Accelerometer ratio)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Carina Maximum Stable Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Current Adult Recipients of Cochlear Carina System', 'description': 'Adults who are current recipients of the Cochlear Carina System. Participants will attend one scheduled visit where several acoustic measurements will be taken that do not require active participation by the participant.\n\nNon-interventional, post-market, pilot study of Carina Cochlear System: Several objective acoustic measurements will be performed that do not require active participation from the subject.'}], 'classes': [{'title': 'Ear Canal Open', 'categories': [{'measurements': [{'value': '33.2', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '40.7'}]}]}, {'title': 'Ear Canal plugged', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '2.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from date of enrolment through to study visit, an average of 1 month', 'description': 'Transfer function from Carina output to actuator \\[dB FS\\] to Carina input from implanted microphone \\[dB FS\\], for audiometric frequencies 250-6000 Hz, with ear canal open and ear canal plugged.', 'unitOfMeasure': 'dB', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Carina Microphone Impulse Response for Acoustic and Actuator Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Current Adult Recipients of Cochlear Carina System', 'description': 'Adults who are current recipients of the Cochlear Carina System. Participants will attend one scheduled visit where several acoustic measurements will be taken that do not require active participation by the participant.\n\nNon-interventional, post-market, pilot study of Carina Cochlear System: Several objective acoustic measurements will be performed that do not require active participation from the subject.'}], 'classes': [{'title': 'Presence of Vibration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Presence of distortion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from date of enrolment through to study visit, an average of 1 month', 'description': "Identification of the system's acoustic and vibration transfer functions including non-linear components.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Current Adult Recipients of Cochlear Carina System', 'description': 'Adults who are current recipients of the Cochlear Carina System. Participants will attend one scheduled visit where several acoustic measurements will be taken that do not require active participation by the participant.\n\nNon-interventional, post-market, pilot study of Carina Cochlear System: Several objective acoustic measurements will be performed that do not require active participation from the subject.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Current Adult Recipients of Cochlear Carina System', 'description': 'Adults who are current recipients of the Cochlear Carina System. Participants will attend one scheduled visit where several acoustic measurements will be taken that do not require active participation by the participant.\n\nNon-interventional, post-market, pilot study of Carina Cochlear System: Several objective acoustic measurements will be performed that do not require active participation from the subject.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62.4', 'spread': '15.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', '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': 'Portugal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ear (Left/Right)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Left Ear', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Right Ear', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Usage(years)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Microphone Position', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'title': 'A-mastoid tip', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'A-B', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'B-posterior inferior', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'B-C', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'C-posterior mastoid', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'C-D', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'D-posterior', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'E-posterior superior', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of HL, coupling', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Sensorineural HL. incus', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Mixed HL, stapes head', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Mixed HL, "power stapes"', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-06', 'size': 1162435, 'label': 'Study Protocol and Statistical Analysis Plan: CIP CAMSEN AI-5770', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-01T00:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-28', 'studyFirstSubmitDate': '2020-02-10', 'resultsFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2020-02-13', 'lastUpdatePostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-28', 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acoustic Sensitivity of Implanted Carina Microphone', 'timeFrame': 'from date of enrolment through to study visit, an average of 1 month', 'description': 'The acoustic sensitivity of the implanted microphone was measured using a white noise acoustic test signal was presented from a loudspeaker, with the sound pressure level monitored with an external probe microphone positioned over the location of the implanted microphone and the signal level at the implanted microphone recorded through a wireless link to the Carina implant.'}, {'measure': 'Ratio of Response of Carina Microphone : Accelerometer for Acoustic Stimulation', 'timeFrame': 'from date of enrolment through to study visit, an average of 1 month', 'description': 'Ratio \\[dB\\] of response of implanted microphone to response of implanted accelerometer, in-situ, for audiometric frequencies 250-6000 Hz, median and percentiles'}, {'measure': 'Carina Maximum Stable Gain', 'timeFrame': 'from date of enrolment through to study visit, an average of 1 month', 'description': 'Transfer function from Carina output to actuator \\[dB FS\\] to Carina input from implanted microphone \\[dB FS\\], for audiometric frequencies 250-6000 Hz, with ear canal open and ear canal plugged.'}, {'measure': 'Carina Microphone Impulse Response for Acoustic and Actuator Stimulation', 'timeFrame': 'from date of enrolment through to study visit, an average of 1 month', 'description': "Identification of the system's acoustic and vibration transfer functions including non-linear components."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cochlear implantation'], 'conditions': ['Hearing Impairment']}, 'descriptionModule': {'briefSummary': 'This investigation is a single-centre, prospective, single-arm, post-market, non-interventional, pilot clinical investigation designed to characterize microphone sensitivity and maximum stable gain of the Cochlear Carina System.', 'detailedDescription': 'The totally implanted Carina System is an active middle ear implant where all components are implanted under the skin. Placing a microphone under the skin affects its acoustic sensitivity and vibration sensitivity. Software is now available to enable non-intrusive microphone measurements in existing patients with the Carina device, through a wireless link to the implant. Detailed knowledge of the acoustic sensitivity of the implanted microphone and objectively measured maximum stable gain, and its inter-individual variability, will allow more accurate calculation of overall system performance, and thereby more accurate prediction of clinical outcomes.\n\nSubjects will attend one scheduled study visit to be assessed; several objective acoustic measurements will be performed that do not require active participation from the subject. No data monitoring committee will be used for this clinical investigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Current adult recipient of a Cochlear Carina System.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eighteen years of age or older at the time of enrolment in the study\n* Current recipient of a Cochlear Carina System.\n\nExclusion Criteria:\n\n\\- Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator.'}, 'identificationModule': {'nctId': 'NCT04271761', 'acronym': 'CAMSEN', 'briefTitle': 'Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cochlear'}, 'officialTitle': 'A Prospective, Single-centre Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients', 'orgStudyIdInfo': {'id': 'AI-5770'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Current adult recipients of Cochlear Carina System', 'description': 'Adults who are current recipients of the Cochlear Carina System. Participants will attend one scheduled visit where several acoustic measurements will be taken that do not require active participation by the participant.', 'interventionNames': ['Other: Non-interventional, post-market, pilot study of Carina Cochlear System']}], 'interventions': [{'name': 'Non-interventional, post-market, pilot study of Carina Cochlear System', 'type': 'OTHER', 'description': 'Several objective acoustic measurements will be performed that do not require active participation from the subject.', 'armGroupLabels': ['Current adult recipients of Cochlear Carina System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4100-180', 'city': 'Porto', 'country': 'Portugal', 'facility': 'CUF Porto Hospital', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'overallOfficials': [{'name': 'Victor Correia da Silva, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CUF Porto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cochlear', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}