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

Recruiting
Conditions
Bacterial Infections
Registration Number
NCT06554145
Lead Sponsor
GramEye
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
15000
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Rate of concordance between AI-estimated results with actual culture results regarding urine Gram stain specimensDay1

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Keio University Hospital

🇯🇵

Shinjuku-Ku, Tokyo, Japan

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