Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-07 @ 1:56 AM
Study NCT ID:
NCT06637995
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2024-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Product Surveillance Registry; Ear, Nose &Amp; Throat - NIM Vital Cohort
Sponsor:
Medtronic
Organization:
Study Overview
Official Title:
Product Surveillance Registry (PSR) - Nerve Integrity Monitoring (NIM) Vital Cohort
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSR-ENT
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: