Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05488535
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2022-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Non-significant Risk Study of a Cochlear Implant Headpiece
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], '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': 'Emily.Cardenas@advancedbionics.com', 'phone': '16616785405', 'title': 'Emily Cardenas, Au.D.', 'organization': 'Advanced Bionics'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Issues were reported either by way of direct communications between the trial participants and investigators (verbal, email, phone, etc.) during the active phase of the study (11 months total).', 'eventGroups': [{'id': 'EG000', 'title': 'Non-significant Risk Study of a Cochlear Implant Headpiece', 'description': 'This arm aims to evaluate a cochlear implant headpiece.\n\ncochlear implant headpiece: investigational cochlear implant headpiece', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 5, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Device Temperature', 'notes': 'Report of investigational device being hot to touch and unwearable. Use of the device was discontinued and returned for analysis, no issue found. No further issues were reported. The issue considered resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Subject reported dizziness when using the investigation device while wearing a headband. After removal of the headband, subject reported feeling dizzy. Subject returned to personal device with a headband. No additional issues were reported.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Subject reported experiencing headaches for several months using the investigational device. Subject stopped wearing the investigational device and returned to personal device. Subject reported headaches resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Redness', 'notes': 'Subject self-reported redness of the skin from the investigational device. Site was checked by their audiologist. No redness was reported. The subject continued using the investigational device without incident.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Skin Flap Thinning Procedure', 'notes': 'The investigational headpiece and magnet were not sufficient in providing acceptable and comfortable retention. Subject had skin flap thinning procedure to ensure headpiece retention was acceptable.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Report of Headpiece Comfort and Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-significant Risk Study of a Cochlear Implant Headpiece', 'description': 'This arm aims to evaluate a cochlear implant headpiece.\n\ncochlear implant headpiece: investigational cochlear implant headpiece'}], 'classes': [{'title': 'Favorable Retention Rating', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': 'Favorable Comfort Rating', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed every two months from month 2 to month 12, values at study close out (month 12) reported.', 'description': 'Comfort and subjective retention of the headpiece were rated via questionnaire for baseline headpiece and investigational headpiece acute and chronic use. Subjects were provided with ratings questionnaires and asked to chronically evaluate the headpiece and associated magnet for comfort and retention every two months. Results are presented as total count of participants who rated retention and comfort as favorable ("no opinion," "acceptable," or "very acceptable") at study close out.\n\nThe baseline/investigational headpiece questionnaires included 2 questions:\n\n1. Rate the retention of your personal/investigational headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable)\n2. Rate the comfort of your personal headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject count at baseline (n=100, includes all subjects enrolled) differ from the overall number of participants analyzed at study close-out (n=72, includes all subjects who were wearing headpiece at the end of the study and who completed final questionnaire).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study', 'description': 'Participants eligible to participate in this study were evaluated according to the inclusion requirements for the study. Informed consent was obtained before any study-specific tests or procedures are conducted. An individual was considered to be enrolled as a study participant only after the informed consent document was signed and dated. Each participant was assigned a unique identifier at the time of enrollment. There was only one group of participants for the overall study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-significant Risk Study of a Cochlear Implant Headpiece', 'description': 'This arm aims to evaluate a cochlear implant headpiece.\n\ncochlear implant headpiece: investigational cochlear implant headpiece'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '92'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '70', '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': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2019-01-25', 'size': 12103024, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-31T15:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2020-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-24', 'studyFirstSubmitDate': '2022-07-26', 'resultsFirstSubmitDate': '2023-08-10', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-24', 'studyFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Report of Headpiece Comfort and Retention', 'timeFrame': 'Assessed every two months from month 2 to month 12, values at study close out (month 12) reported.', 'description': 'Comfort and subjective retention of the headpiece were rated via questionnaire for baseline headpiece and investigational headpiece acute and chronic use. Subjects were provided with ratings questionnaires and asked to chronically evaluate the headpiece and associated magnet for comfort and retention every two months. Results are presented as total count of participants who rated retention and comfort as favorable ("no opinion," "acceptable," or "very acceptable") at study close out.\n\nThe baseline/investigational headpiece questionnaires included 2 questions:\n\n1. Rate the retention of your personal/investigational headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable)\n2. Rate the comfort of your personal headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isUnapprovedDevice': True}, 'conditionsModule': {'keywords': ['cochlear implant'], 'conditions': ['Hearing Loss', 'Sensorineural Hearing Loss']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate a cochlear implant headpiece.', 'detailedDescription': 'The headpiece and magnet are expected to provide acceptable comfort and retention for existing cochlear implant users. In this study participants will report on their experience with the investigational headpiece during daily life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre- or post-lingually deafened.\n* Fluent in English, French, or Spanish or capable of communication with a caregiver who is providing consent.\n* Adult or child implanted with a commercially available Advanced Bionics cochlear implant. Children and adult participants are included to ensure device retention is appropriate for all implant populations.\n* Have (or caregivers have) the cognitive and functional capability to comply with all directions during the study\n* Be able to remove their own headpiece\n* Have (or caregivers have) the cognitive and functional capability to complete the questionnaire required for the study\n* Capable (or caregivers are capable) of reading and understanding patient information materials and giving written informed consent\n\nExclusion Criteria:\n\n* Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study data.'}, 'identificationModule': {'nctId': 'NCT05488535', 'briefTitle': 'Non-significant Risk Study of a Cochlear Implant Headpiece', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanced Bionics'}, 'officialTitle': 'Non-significant Risk Study of a Cochlear Implant Headpiece', 'orgStudyIdInfo': {'id': '20190256'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-significant risk study of a cochlear implant headpiece', 'description': 'This arm aims to evaluate a cochlear implant headpiece.', 'interventionNames': ['Device: cochlear implant headpiece']}], 'interventions': [{'name': 'cochlear implant headpiece', 'type': 'DEVICE', 'description': 'investigational cochlear implant headpiece', 'armGroupLabels': ['Non-significant risk study of a cochlear implant headpiece']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91355', 'city': 'Valencia', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Bionics', 'geoPoint': {'lat': 34.44361, 'lon': -118.60953}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanced Bionics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}