Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-01 @ 3:17 PM
Study NCT ID:
NCT06306534
Status:
RECRUITING
Last Update Posted:
2025-01-15
First Post:
2024-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auditory Intranerve Stimulation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000160', 'term': 'Vestibulocochlear Nerve Diseases'}], 'ancestors': [{'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-03-05', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Collection of adverse events', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Auditory; Nerve']}, 'descriptionModule': {'briefSummary': 'This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent\n2. Patients who will undergo an acoustic neuroma removal surgery and are functional deaf\n3. Age ≥ 18 years\n4. Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists\n\nExclusion Criteria:\n\n1. Disabilities in addition to hearing impairment which might interfere with the study procedure\n2. Pregnant and breast feeding woman or other vulnerable population'}, 'identificationModule': {'nctId': 'NCT06306534', 'acronym': 'AIS', 'briefTitle': 'Auditory Intranerve Stimulation Study', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Intraoperative Acute Study to Evaluate Auditory Intranerve Stimulation', 'orgStudyIdInfo': {'id': 'AIS-001'}, 'secondaryIdInfos': [{'id': 'CIV-22-05-039592', 'type': 'OTHER_GRANT', 'domain': 'Blackrock Neurotech'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insert Array Into Auditory Nerve', 'interventionNames': ['Other: Auditory Nerve Acute (ANA) Electrode Array']}], 'interventions': [{'name': 'Auditory Nerve Acute (ANA) Electrode Array', 'type': 'OTHER', 'description': 'To measure eABRs when stimulating the human auditory nerve', 'armGroupLabels': ['Insert Array Into Auditory Nerve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Karl-Heinz Dyballa', 'role': 'CONTACT', 'email': 'dyballa.karl-heinz@mh-hannover.de'}], 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'centralContacts': [{'name': 'Karl-Heinz Dyballa', 'role': 'CONTACT', 'email': 'dyballa.karl-heinz@mh-hannover.de', 'phone': '+4917615328589'}], 'overallOfficials': [{'name': 'Thomas Lenarz, Prof. Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School, Director of otorhinolaryngology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}