Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637995
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Product Surveillance Registry Ear Nose Amp Throat - NIM Vital Cohort
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Product Surveillance Registry PSR - Nerve Integrity Monitoring NIM Vital Cohort
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 Medtronics NIM Vital System and accessories when used as intended in a real-world setting
Detailed Description:
Ongoing clinical investigation for the purposes 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 servicessolutions
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 servicessolutions
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:
None
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?:
None
Is an FDA AA801 Violation?:
None