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

Recruiting

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

• Registration Number: NCT06637995
• Lead Sponsor: Medtronic

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Study Start: 2025-01-27
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2026-02
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Event Rate	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.

Secondary Outcome Measures

Name	Time	Method
Device Performance	During baseline procedure	Incidence of successful location, monitoring, and stimulation of target nerve, open airway for patient ventilation and EMG monitoring.

Trial Locations

Locations (1)

Universitatsklinikum Halle (Saale); 🇩🇪 Halle, Germany