Product Surveillance Registry; Ear, Nose &Amp; Throat - NIM Vital Cohort (PSR-ENT)

September 23, 2025 updated by: Medtronic

Product Surveillance Registry (PSR) - Nerve Integrity Monitoring (NIM) Vital Cohort

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

205

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Halle, Germany
        • Universitätsklinikum Halle (Saale)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event Rate
Time Frame: 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.
From enrollment to resolution of AE, or up to 6months following baseline procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Performance
Time Frame: During baseline procedure
Incidence of successful location, monitoring, and stimulation of target nerve, open airway for patient ventilation and EMG monitoring.
During baseline procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2025

Primary Completion (Actual)

July 3, 2025

Study Completion (Actual)

July 3, 2025

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSR ENT - NIM Vital Cohort

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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