Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05722639
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2023-01-23
Brief Title:
Evaluation of Accuracy and Consistency of the X-Trodes System
Sponsor:
B-Cube
Organization:
B-Cube
Study Overview
Official Title:
Evaluation of Accuracy and Consistency of the X-Trodes System
Status:
COMPLETED
Status Verified Date:
2024-02
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:
The purpose of this study is to evaluate the accuracy and consistency of the X-Trodes acquisition system compared to a Food and Drug Administration FDA-cleared clinical electrophysiology device
Detailed Description:
The study aims to demonstrate that the performance of the study X-Trodes acquisition system is equivalent to that of an FDA-cleared clinical electrophysiology devices in measuring electroencephalography electrooculography electromyography and electrocardiogram signals
Subjects will wear both devices simultaneously while signals are captured in resting state Following an evaluation of the similarity of signals between the two devices will be conducted The evaluation will determine if the quality of the X-Trodes system matches that of the FDA-approved device
Subjects will wear both devices simultaneously while signals are captured in resting state Following an evaluation of the similarity of signals between the two devices will be conducted The evaluation will determine if the quality of the X-Trodes system matches that of the FDA-approved device
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?:
False
Is an FDA AA801 Violation?:
None