Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368024
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2023-11-26
Brief Title:
Establishment of Delphi-MD Safety Performance and Reliability
Sponsor:
QuantalX Neuroscience
Organization:
QuantalX Neuroscience
Study Overview
Official Title:
Establishment of Delphi-MD Safety Performance and Reliability
Status:
COMPLETED
Status Verified Date:
2024-04
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:
None
Brief Summary:
A retrospective analysis of collected datasets In this study we aim to establish Delphi-MDs safety and performance reliability for assessment and monitoring of Transcranial Magnetic Stimulation TMS Evoked Potentials TEPs as neurophysiological measurements
Detailed Description:
A retrospective analysis of collected datasets In this study we aim to establish Delphi-MDs safety and reliability for assessment and monitoring of TEPs as neurophysiological measurements
Safety
Upper limit of the 95 CI of the device related serious adverse event SAE rate is less than or equal to 36
Performance
Demonstrate differentiation of relevant clinical groups
Reliability
An acceptable mean Interclass correlation ICC statistic six stimulation is at least 06 Additionally the within subject variability should be lower than the between subject variability
Safety
Upper limit of the 95 CI of the device related serious adverse event SAE rate is less than or equal to 36
Performance
Demonstrate differentiation of relevant clinical groups
Reliability
An acceptable mean Interclass correlation ICC statistic six stimulation is at least 06 Additionally the within subject variability should be lower than the between subject variability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None