Extracranial Surgery, Extratemporal Surgery, Intracranial Surgery, Intratemporal Surgery, Lower Extremity Surgery, Neck Surgery, Spine Surgery, Thoracic Surgery, Upper Extremity Surgery
Conditions
Keywords
Nerve Monitoring, EMG Monitoring, Nerve Integrity
Brief summary
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.
Detailed description
Ongoing clinical investigation for the purpose(s) of: * Providing continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use * 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 * 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 * Obtaining clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, and patient services/solutions * Providing clinical data to support health economics and clinical outcomes research 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.
Interventions
Observational data collection from Locating, Stimulating, and Monitoring target nerves during a surgical procedure (clinician standard of care)
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements. * Patient has or is intended to receive or be treated with an eligible Medtronic product * Patient is consented within the enrollment window of the therapy received, as applicable
Exclusion criteria
* Patient who is, or is expected to be, inaccessible for follow-up * Participation is excluded by local law * Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Rate | From enrollment to resolution of AE, or up to 6months following baseline procedure. | Rate of adverse events caused directly by the NIM Vital™ System and/or accessories by determination and quantification of safety related complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Performance | During baseline procedure | Incidence of successful location, monitoring, and stimulation of target nerve, open airway for patient ventilation and EMG monitoring. |
Countries
Germany
Outcome results
None listed