Ignite Creation Date:
2024-05-06 @ 6:11 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05572619
Status:
COMPLETED
Last Update Posted:
2022-10-07
First Post:
2022-10-04
Brief Title:
Evaluation of Clinical Decision Support System for Large Vessel Occlusion Using Brain CT Images
Sponsor:
Heuron Inc
Organization:
Heuron Inc
Study Overview
Official Title:
An Open Label Single-center Retrospective Pivotal Study to Evaluate the Efficacy of Clinical Decision Support System for Large Vessel Occlusion Using Brain CT Images
Status:
COMPLETED
Status Verified Date:
2022-10
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:
cELVO is a software that has been pre-learned based on a large vessel occlusion diagnosis model using brain CT images and clinical decision support system for diagnosing large vessel occlusion by automatically analyzing brain CT images by assisting the medical team
The specific aims of this study are to evaluate efficacy of cELVO compared to the sensitivity and specificity levels of medical team to diagnosis with and without cELVO used
The specific aims of this study are to evaluate efficacy of cELVO compared to the sensitivity and specificity levels of medical team to diagnosis with and without cELVO used
Detailed Description:
None
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