Product Surveillance Registry; Ear, Nose &Amp; Throat - NIM Vital Cohort

NCT06637995 | Completed

• 1 other identifier: PSR ENT - NIM Vital Cohort
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Surgery; Extracranial Surgery; Intratemporal Surgery; Extratemporal Surgery; Neck Surgery; Spine Surgery; Thoracic Surgery; Upper Extremity Surgery; Lower Extremity Surgery

Keywords

Nerve Monitoring; EMG Monitoring; Nerve Integrity

Outcome Measures

Primary Outcomes (1)

• Adverse Event Rate

  Rate of adverse events caused directly by the NIM Vital™ 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.

Secondary Outcomes (1)

• Device Performance

  During baseline procedure

Interventions

Intraoperative Nerve Monitoring DEVICE

Observational data collection from Locating, Stimulating, and Monitoring target nerves during a surgical procedure (clinician standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic: lead

Study Sites (1)

Universitatsklinikum Halle (Saale)

Halle, Germany

Location

MeSH Terms

Interventions

Intraoperative Neurophysiological Monitoring

Intervention Hierarchy (Ancestors)

Monitoring, Intraoperative; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Neurophysiological Monitoring; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 15, 2024
• Study Start: January 27, 2025
• Primary Completion: July 3, 2025
• Study Completion: July 3, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)