Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-06-14 @ 6:45 AM
Study NCT ID:
NCT05095220
Status:
COMPLETED
Last Update Posted:
2023-05-22
First Post:
2021-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integration of NAVOY® Sepsis in an Electronic Health Record System
Sponsor:
AlgoDx
Organization:
Study Overview
Official Title:
Integration and Evaluation of a Machine Learning Algorithm for Sepsis Prediction in an Electronic Health Record System - a Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2023-05
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:
GENIUS
Brief Summary:
The study aims to evaluate the performance of NAVOY® Sepsis in predicting the sepsis risk in adult ICU patients. Data collection is performed via automatic retrieval from the electronic health record system to AlgoDx proprietary cloud service where it is analysed in a simulated environment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: