Monitoring the safety and performance of Medtronic's NIM Vital System in surgeries
Product Surveillance Registry (PSR) - Nerve Integrity Monitoring (NIM) Vital Cohort
This study is testing how safe and effective Medtronic's NIM Vital System is during different types of surgeries, using data from hospitals around the world.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic Industry-sponsored |
| Locations | 1 site (Halle) |
| Trial ID | NCT06637995 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical safety and performance of Medtronic's NIM Vital™ System and its accessories in real-world surgical settings. It involves collecting data from a global network of hospitals and clinics to assess the effectiveness of the device during various types of surgeries, including intracranial and neck surgeries. The study is ambispective, allowing for patient enrollment up to 60 days before or after the surgical procedure, with follow-up only if a reportable event occurs. The goal is to gather clinical evidence that can inform device improvements and support health economics research.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for surgeries involving the use of Medtronic's NIM Vital System.
Not a fit: Patients who are not undergoing eligible surgeries or are enrolled in concurrent studies that may affect the results will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of nerve monitoring during surgeries, potentially leading to better patient outcomes.
How similar studies have performed: Other studies have shown success in monitoring nerve integrity during surgeries, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Halle
- Universitatsklinikum Halle (Saale) — Halle, Germany (Recruiting)
Study contacts
- Study coordinator: Demarcus Williams
- Email: demarcus.a.williams@medtronic.com
- Phone: 904-296-9600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.