Ignite Creation Date:
2024-07-17 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499220
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-06-18
Brief Title:
Electrically Evoked Compound Action Potentials Human Observation Medtronic System Study ECHO-MDT
Sponsor:
MedtronicNeuro
Organization:
MedtronicNeuro
Study Overview
Official Title:
Electrically Evoked Compound Action Potentials Human Observation Medtronic System Study ECHO-MDT
Status:
COMPLETED
Status Verified Date:
2024-07
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:
ECHO-MDT
Brief Summary:
This is a prospective multi-center non-significant risk IDE study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system comprised of Medtronic hardware or off the shelf hardware which uses recorded waveforms to adjust stimulation amplitude
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None