Trials / Completed
CompletedNCT06637995
Product Surveillance Registry; Ear, Nose &Amp; Throat - NIM Vital Cohort
Product Surveillance Registry (PSR) - Nerve Integrity Monitoring (NIM) Vital Cohort
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 205 (actual)
- Sponsor
- Medtronic · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Intracranial Surgery
- Extracranial Surgery
- Intratemporal Surgery
- Extratemporal Surgery
- Neck Surgery
- Spine Surgery
- Thoracic Surgery
- Upper Extremity Surgery
- Lower Extremity Surgery
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intraoperative Nerve Monitoring | Observational data collection from Locating, Stimulating, and Monitoring target nerves during a surgical procedure (clinician standard of care) |
Timeline
- Start date
- 2025-01-27
- Primary completion
- 2025-07-03
- Completion
- 2025-07-03
- First posted
- 2024-10-15
- Last updated
- 2025-09-24
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT06637995. Inclusion in this directory is not an endorsement.