Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-03-25 @ 5:54 PM
Study NCT ID:
NCT06637995
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2024-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Product Surveillance Registry; Ear, Nose &Amp; Throat - NIM Vital Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064795', 'term': 'Intraoperative Neurophysiological Monitoring'}], 'ancestors': [{'id': 'D016343', 'term': 'Monitoring, Intraoperative'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D064926', 'term': 'Neurophysiological Monitoring'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2024-10-09', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event Rate', 'timeFrame': 'From enrollment to resolution of AE, or up to 6months following baseline procedure.', 'description': 'Rate of adverse events caused directly by the NIM Vital™ System and/or accessories by determination and quantification of safety related complications.'}], 'secondaryOutcomes': [{'measure': 'Device Performance', 'timeFrame': 'During baseline procedure', 'description': 'Incidence of successful location, monitoring, and stimulation of target nerve, open airway for patient ventilation and EMG monitoring.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nerve Monitoring', 'EMG Monitoring', 'Nerve Integrity'], 'conditions': ['Intracranial Surgery', 'Extracranial Surgery', 'Intratemporal Surgery', 'Extratemporal Surgery', 'Neck Surgery', 'Spine Surgery', 'Thoracic Surgery', 'Upper Extremity Surgery', 'Lower Extremity Surgery']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to confirm clinical safety and performance of Medtronic's NIM Vital™ System and accessories when used as intended in a real-world setting.", 'detailedDescription': 'Ongoing clinical investigation for the purpose(s) of:\n\n* Providing continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use\n* Obtaining real-world performance and safety information from a global network of hospitals, clinics, and clinicians intended to represent the range of clinical environments in which Medtronic products are used\n* Supporting post-market surveillance activities and post-approval studies that are initiated by Medtronic, regulated by local governments, or are conducted to fulfill government and/ or regulatory authority requests\n* Obtaining clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, and patient services/solutions\n* Providing clinical data to support health economics and clinical outcomes research\n\nEnrollment for this study is ambispective, and subjects can be enrolled up to 60 days before or after the baseline procedure. There is no scheduled follow-up visit, however, if a reportable event occurs, patients will be followed until resolution or up to 6 months following the procedure. Total duration for study participants is anticipated to be 1 visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing surgical procedures using the NIM Vital™ system and accessories for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor and mixed motor-sensory nerves and registering electromyography (EMG) responses during surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.\n* Patient has or is intended to receive or be treated with an eligible Medtronic product\n* Patient is consented within the enrollment window of the therapy received, as applicable\n\nExclusion Criteria:\n\n* Patient who is, or is expected to be, inaccessible for follow-up\n* Participation is excluded by local law\n* Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results'}, 'identificationModule': {'nctId': 'NCT06637995', 'acronym': 'PSR-ENT', 'briefTitle': 'Product Surveillance Registry; Ear, Nose &Amp; Throat - NIM Vital Cohort', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic'}, 'officialTitle': 'Product Surveillance Registry (PSR) - Nerve Integrity Monitoring (NIM) Vital Cohort', 'orgStudyIdInfo': {'id': 'PSR ENT - NIM Vital Cohort'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intraoperative Nerve Monitoring', 'type': 'DEVICE', 'description': 'Observational data collection from Locating, Stimulating, and Monitoring target nerves during a surgical procedure (clinician standard of care)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Halle', 'country': 'Germany', 'facility': 'Universitatsklinikum Halle (Saale)', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}