Development and Evaluation of AI Program for Predicting Bacterial Species From Urine Gram Stain Specimens
- 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
- Specimens for which urine culture and urine Gram staining tests were performed for clinical purposes
- Samples for which suspension of use has been requested
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Keio University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan