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Clinical Trials in Japan / NCT06554145
Recruiting Observational

Development and Evaluation of AI Program for Predicting Bacterial Species From Urine Gram Stain Specimens

NCT06554145 · tracked via the Priya Life Science Japan tracker
Sponsor
GramEye
Phase
Observational
Started
2023-09-25
Last updated
2024-08-15

Condition(s) studied

Bacterial Infections

Study summary

The purpose of this research is to develop an AI that estimates bacterial species from Gram staining images of urine specimens, and to evaluate the accuracy and labor reduction effect of Gram staining Automation system equipped with this AI.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Specimens for which urine culture and urine Gram staining tests were performed for clinical purposes Exclusion Criteria: * Samples for which suspension of use has been requested

Primary outcome measure(s)

  • Rate of concordance between AI-estimated results with actual culture results regarding urine Gram stain specimens — Day1
    Evaluate the concordance rate between bacterial species estimation results and culture results obtained using the automatic Gram staining device with an AI program installed for analyzing urine Gram stain specimens.

Trial sites (1)

FacilityCityRegionStatus
Keio University Hospital Shinjuku-Ku Tokyo Recruiting

More GramEye trials in Japan

Development and Accuracy Evaluation of Gram Staining Analysis AI Recruiting
Development and Evaluation of Rapid Bacterial Species Identification for Acid-Fast Bacilli Smear Using Image Analysis AI Recruiting

Other trials for the same condition

Development and Accuracy Evaluation of Gram Staining Analysis AI Recruiting
Development and Evaluation of Rapid Bacterial Species Identification for Acid-Fast Bacilli Smear Using Image Analysis AI Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06554145 on ClinicalTrials.gov ↗ ← All trials in Japan