Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-09 @ 10:56 PM
Study NCT ID:
NCT03172520
Status:
TERMINATED
Last Update Posted:
2020-01-18
First Post:
2017-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Automatic Periodic Stimulation and Continuous Electromyography (EMG) for Facial Nerve Monitoring During Parotidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Moore.Eric@mayo.edu', 'phone': '507-284-3853', 'title': 'Eric J. Moore, M.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected over a two day period.', 'eventGroups': [{'id': 'EG000', 'title': 'Facial Nerve Monitoring With APS Electrode', 'description': 'The investigators will use the Facial Nerve Monitor along with the APS electrode during parotidectomy surgery.\n\nAPS electrode: The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.\n\nFacial Nerve Monitor: The facial nerve monitoring system records the number of stimulations of the facial nerve during the operation and this data is stored on the device until it is shut down after the surgery is complete.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Electromyography (EMG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Facial Nerve Monitoring With APS Electrode', 'description': 'The investigators will use the Facial Nerve Monitor along with the APS electrode during parotidectomy surgery.\n\nAPS electrode: The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.\n\nFacial Nerve Monitor: The facial nerve monitoring system records the number of stimulations of the facial nerve during the operation and this data is stored on the device until it is shut down after the surgery is complete.'}], 'timeFrame': 'baseline, approximately 3 hours', 'description': 'EMG is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated due to limitations in timing and personnel. Data was not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Facial Nerve Monitoring With APS Electrode', 'description': 'The investigators will use the Facial Nerve Monitor along with the automatic periodic stimulating (APS) electrode during parotidectomy surgery.\n\nAPS electrode: The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.\n\nFacial Nerve Monitor: The facial nerve monitoring system records the number of stimulations of the facial nerve during the operation and this data is stored on the device until it is shut down after the surgery is complete.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Facial Nerve Monitoring With APS Electrode', 'description': 'The investigators will use the Facial Nerve Monitor along with the APS electrode during parotidectomy surgery.\n\nAPS electrode: The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.\n\nFacial Nerve Monitor: The facial nerve monitoring system records the number of stimulations of the facial nerve during the operation and this data is stored on the device until it is shut down after the surgery is complete.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59.67', 'spread': '14.47', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', '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': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2016-11-21', 'size': 643234, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-28T12:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Limitations in timing and personnel', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-14', 'studyFirstSubmitDate': '2017-05-30', 'resultsFirstSubmitDate': '2019-05-30', 'studyFirstSubmitQcDate': '2017-05-30', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-14', 'studyFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Electromyography (EMG)', 'timeFrame': 'baseline, approximately 3 hours', 'description': 'EMG is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Parotidectomy'], 'conditions': ['Parotid Gland Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to document the safety of the Medtronic automatic periodic stimulating (APS) Electrode Stimulator during a parotidectomy and potentially prevent post-operative facial nerve weakness, which is a relatively common outcome after parotid surgery.', 'detailedDescription': 'This study will be conducted in two phases. In the first phase the investigators will use the same monitoring system currently used during parotidectomy and requires placement of the APS electrode as the only additional piece of equipment. During this phase, the investigators will record intraoperative EMG data generated by the monitoring system as well as document intra-operative maneuvers that precede adverse EMG events.\n\nIn the second phase of the study the investigators aim to allow the surgeon to alter his or her techniques, with the information provided by the APS electrode, to reverse adverse EMG changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parotidectomy: Planned parotid gland surgery (superficial or total parotidectomy)\n* Benign or malignant disease\n\nExclusion Criteria:\n\n* Current pregnancy\n* Preoperative facial nerve dysfunction\n* Revision surgery\n* History of preoperative radiation to the surgical field\n* Retrograde or extracapsular dissection\n* Intentional nerve sacrifice (i.e., due to nerve involvement by tumor)\n* Tumors with proximity to main trunk of facial nerve\n* Inability to place electrode\n* Presence of electrode alters surgical technique'}, 'identificationModule': {'nctId': 'NCT03172520', 'briefTitle': 'Automatic Periodic Stimulation and Continuous Electromyography (EMG) for Facial Nerve Monitoring During Parotidectomy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Use of Automatic Periodic Stimulation and Continuous EMG for Facial Nerve Monitoring During Parotidectomy', 'orgStudyIdInfo': {'id': '16-009380'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Facial Nerve Monitoring with APS electrode', 'description': 'The investigators will use the Facial Nerve Monitor along with the automatic periodic stimulating(APS) electrode during parotidectomy surgery.', 'interventionNames': ['Device: APS electrode', 'Device: Facial Nerve Monitor']}], 'interventions': [{'name': 'APS electrode', 'type': 'DEVICE', 'otherNames': ['automatic periodic stimulating (APS) Electrode Stimulator'], 'description': 'The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.', 'armGroupLabels': ['Facial Nerve Monitoring with APS electrode']}, {'name': 'Facial Nerve Monitor', 'type': 'DEVICE', 'otherNames': ['NIM-Response 3.0'], 'description': 'The facial nerve monitoring system records the number of stimulations of the facial nerve during the operation and this data is stored on the device until it is shut down after the surgery is complete.', 'armGroupLabels': ['Facial Nerve Monitoring with APS electrode']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Eric J Moore', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Otolaryngology', 'investigatorFullName': 'Eric J. Moore, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}