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The purpose of this study is to confirm clinical safety and performance of Medtronic's NIM Vitalâ„¢ System and accessories when used as intended in a real-world setting.
Ongoing clinical investigation for the purpose(s) of:
Enrollment 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative Nerve Monitoring | Device | Observational data collection from Locating, Stimulating, and Monitoring target nerves during a surgical procedure (clinician standard of care) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Rate | Rate of adverse events caused directly by the NIM Vitalâ„¢ System and/or accessories by determination and quantification of safety related complications. | From enrollment to resolution of AE, or up to 6months following baseline procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Device Performance | Incidence of successful location, monitoring, and stimulation of target nerve, open airway for patient ventilation and EMG monitoring. | During baseline procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing surgical procedures using the NIM Vitalâ„¢ 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitatsklinikum Halle (Saale) | Halle | Germany |
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| ID | Term |
|---|---|
| D064795 | Intraoperative Neurophysiological Monitoring |
| ID | Term |
|---|---|
| D016343 | Monitoring, Intraoperative |
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D064926 | Neurophysiological Monitoring |
| D013514 | Surgical Procedures, Operative |
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