Clinical trial NCT06637995: Product Surveillance Registry; Ear, Nose &amp; Throat - NIM Vital Cohort
Official title: Product Surveillance Registry (PSR) - Nerve Integrity Monitoring (NIM) Vital Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility 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

Primary outcomes:
measure: Adverse Event Rate
timeFrame: From enrollment to resolution of AE, or up to 6months following baseline procedure.
Secondary outcomes:
measure: Device Performance
timeFrame: During baseline procedure
Other outcomes:
Locations:
city: Halle
country: Germany
facility: Universitatsklinikum Halle (Saale)
Study officials:
References: