Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-11-16
Brief Title:
Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device
Sponsor:
GramEye
Organization:
GramEye
Study Overview
Official Title:
Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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 investigators have developed an analysis AI for Gram staining In this study the investigators will compare the testing accuracy of automated Gram staining equipment with AI with the testing accuracy of laboratory technicians Based on the results the investigators will examine the possibility of clinical application of the automated Gram staining device
Detailed Description:
Gram stainingwhitch provides crucial information for selecting antibiotics in the diagnosis and treatment of infectious diseases is often manually performed in many laboratories and the microscopic findings are subjectively interpreted and reported based on the experience of laboratory technicians Automating the entire process from staining to microscopic examination as achieved by the AI-equipped automatic Gram staining device can reduce the labor required for Gram staining This automation enables even less experienced technicians to quickly report Gram staining results
The aim of this study is to evaluate the accuracy of the Auto microscopic examination of Gram-stained samples using anonymized processed slides created from clinical specimens This evaluation will be compared with the accuracy of microscopic examinations performed by hospital laboratory technicians
If the accuracy of the machine is demonstrated it can be registered as a medical device and proceed to the implementation stage in actual clinical settings The implementation of this device in clinical laboratories is expected to reduce workload expedite processes and contribute to the optimization of antibiotic use based on Gram staining results
The aim of this study is to evaluate the accuracy of the Auto microscopic examination of Gram-stained samples using anonymized processed slides created from clinical specimens This evaluation will be compared with the accuracy of microscopic examinations performed by hospital laboratory technicians
If the accuracy of the machine is demonstrated it can be registered as a medical device and proceed to the implementation stage in actual clinical settings The implementation of this device in clinical laboratories is expected to reduce workload expedite processes and contribute to the optimization of antibiotic use based on Gram staining results
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