Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT06499220
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrically Evoked Compound Action Potentials Human Observation Medtronic System Study (ECHO-MDT)
Sponsor:
MedtronicNeuro
Organization:
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:
False
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?: