Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-02-27 @ 1:09 AM
Study NCT ID:
NCT03745560
Status:
RECRUITING
Last Update Posted:
2024-11-25
First Post:
2018-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative EABR for Decision Making
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009464', 'term': 'Neuroma, Acoustic'}, {'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'id': 'D009442', 'term': 'Neurilemmoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009463', 'term': 'Neuroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D003390', 'term': 'Cranial Nerve Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D000160', 'term': 'Vestibulocochlear Nerve Diseases'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-05-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2018-11-03', 'studyFirstSubmitQcDate': '2018-11-16', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of eABR results to postoperative hearing results', 'timeFrame': '2 years', 'description': 'eABR is correlated with postoperative hearing results eABR will be divided in three categories - good response, weak response, no response.\n\nHearing results will be measured with speech understanding in Freiburg monosyllables word test which is measured in % of monosyllables understanding at 65 and 80dB'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cochlear implant'], 'conditions': ['Vestibular Schwannoma', 'Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '39284021', 'type': 'DERIVED', 'citation': 'Gadenstaetter AJ, Auinger AB, Gerlitz M, Riss D, Yildiz E, Roessler K, Matula C, Dahm V, Arnoldner C. Long-Term Follow-Up After Translabyrinthine IAC Tumor Removal With Simultaneous Cochlear Implantation. Otol Neurotol. 2024 Sep 6. doi: 10.1097/MAO.0000000000004313. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'In this study patients undergoing simultaneous translabyrinthine vestibular schwannoma resection and cochlear implantation are included. The goal of the study is to correlate the eABR results with postoperative hearing results.', 'detailedDescription': 'Patients undergoing translabyrinthine vestibular schwannoma resection are included in the study. Preoperatively an eABR is carried out, as well as before and after tumor resection.\n\nPostoperatively patients are fitted with a cochlear implant as routinely carried out. The postoperative hearing results with cochlear implant are correlated to the eABR results. The study is an observational study since eABR measurements are not part of the study. A correlation between eABR results categorized in three groups (good response, weak response, no response) with monosyllable understanding with cochlear implant (measured with Freiburger monosyllables test).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing translabyrinthine vestibular schwannoma resection and cochlear implantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18 and 99 years undergoing translabyrinthine vestibular schwannoma resection\n* Patients wanted hearing rehabilitation with a cochlear implant\n\nExclusion Criteria:\n\n* patients who do not want to be part of the study'}, 'identificationModule': {'nctId': 'NCT03745560', 'briefTitle': 'Intraoperative EABR for Decision Making', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Simultaneous Translabyrinthine Surgery of Vestibular Schwannoma and Cochlear Implantation with Intraoperative EBERA and Correlation to Hearing Results - a Pilot Study', 'orgStudyIdInfo': {'id': '1111/2017'}}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Valerie Dahm, MD', 'role': 'CONTACT', 'email': 'valerie.dahm@meduniwien.ac.at', 'phone': '004314040033300'}], 'facility': 'AKH, MUW', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Valerie Dahm', 'role': 'CONTACT', 'email': 'valerie.dahm@meduniwien.ac.at', 'phone': '01/40400/33300'}], 'overallOfficials': [{'name': 'Christoph Arnoldner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MUW, Allgemeines Krankenhaus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christoph Arnoldner', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof PD. Dr.', 'investigatorFullName': 'Christoph Arnoldner', 'investigatorAffiliation': 'Medical University of Vienna'}}}}