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

Medtronic205 enrolled

Overview

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.

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

205

Conditions

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

Interventions

Intraoperative Nerve MonitoringDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitatsklinikum Halle (Saale)

Halle, Germany

Outcomes

Primary Outcomes

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.

Time frame: From enrollment to resolution of AE, or up to 6months following baseline procedure.

Secondary Outcomes

Device Performance

Incidence of successful location, monitoring, and stimulation of target nerve, open airway for patient ventilation and EMG monitoring.

Time frame: During baseline procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.