Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device

Infection, Bacterial Clinical Trial

Official title:

Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06143657
• Other study ID #: K22581
• Status: Not yet recruiting
• Start date: January 10, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: GramEye
• Contact: Yamada Tatsuya, M.D.
• Phone: 7028060149
• Email: tatsuya.yamada[@]grameye.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Gram staining,whitch 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1600
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients in whom a Gram stain test was ordered

Exclusion Criteria:

No exclusion criteria

Related Conditions & MeSH terms

• Bacterial Infections
• Infection, Bacterial

Intervention

Diagnostic Test:
• Automated Gram Staining Machine analysis
Measure urine and sputum specimens using this device.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GramEye

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory evaluation items	The difference in accuracy rates of microscopic examination findings by technicians at each facility based on the technicians' years of experience.	Day 1
Primary	Primary Outcome	The difference in accuracy rates between the Gram staining examination performed by laboratory technicians and the automated Gram staining device, including the approximate bacterial quantity based on Gram staining and morphology (categorized as -, 1+, 2+, 3+, 4+), presence of white blood cells, presence of phagocytic images, and, in the case of sputum, the Geckler classification.	Day 1
Secondary	Secondary Outcome	Impact of specimen type and identified bacterial species on testing accuracy.	Day 1