Intracranial SurgeryPSR-ENTNCT06637995
Product Surveillance Registry; Ear, Nose &Amp; Throat - NIM Vital Cohort
An observational study of Intracranial Surgery and Extracranial Surgery, run by Medtronic at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Surgery, Extracranial Surgery, Intratemporal Surgery
- What is being tested?
- Intraoperative Nerve Monitoring
- Type of treatment
- Medical device
- How many people
- 205 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jan 2025to 3 Jul 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Intracranial Surgery, Extracranial Surgery, Intratemporal Surgery, Extratemporal Surgery, Neck Surgery, Spine Surgery
- Being tested
- Intraoperative Nerve Monitoring
- Keywords
- Nerve Monitoring, EMG Monitoring, Nerve Integrity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Nerve MonitoringDevice
Observational data collection from Locating, Stimulating, and Monitoring target nerves during a surgical procedure (clinician standard of care)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to resolution of AE, or up to 6months following baseline procedure.
Secondary outcomes (1)
Device Performance
Incidence of successful location, monitoring, and stimulation of target nerve, open airway for patient ventilation and EMG monitoring.
Measured: During baseline procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start27 Jan 2025
- Primary completion3 Jul 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial SurgeryStudies of the same condition, open and under way.
- More trials run by MedtronicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 205 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637995
- Sponsor's protocol ID
- PSR ENT - NIM Vital Cohort
- Acronym
- PSR-ENT
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Product Surveillance Registry (PSR) - Nerve Integrity Monitoring (NIM) Vital Cohort
- ClinicalTrials.gov ID
- NCT06637995
- Acronym / sponsor ID
- PSR-ENT / PSR ENT - NIM Vital Cohort
- Conditions
- Intracranial Surgery, Extracranial Surgery, Intratemporal Surgery, Extratemporal Surgery, Neck Surgery, Spine Surgery
- Keywords
- Nerve Monitoring, EMG Monitoring, Nerve Integrity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Nerve MonitoringObservational data collection from Locating, Stimulating, and Monitoring target nerves during a surgical procedure (clinician standard of care) | Device | – |
Primary outcome
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.
1 secondary outcome
Device Performance
Time frame: During baseline procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Surgery and Extracranial Surgery, run by Medtronic at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event Rate (time frame: From enrollment to resolution of AE, or up to 6months following baseline procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.