Actively Recruiting
Development and Evaluation of AI Program for Predicting Bacterial Species From Urine Gram Stain Specimens
Led by GramEye · Updated on 2024-08-15
15000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
G
GramEye
Lead Sponsor
K
Keio University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are developing an artificial intelligence (AI) program that can estimate bacterial species from Gram staining images of urine samples. This study focuses on evaluating how accurate the AI predictions are compared to actual urine culture results. The goal is to assess whether this AI-equipped Gram staining Automation system can reduce the labor involved in diagnosing bacterial infections. The study involves observing urine specimens that have undergone both urine culture and Gram staining tests as part of routine clinical care. The AI system will analyze these Gram stain images to predict bacterial species. There are no experimental treatments or interventions being administered to participants, as this is an observational study. Participants provide urine specimens used for clinical testing, which researchers will assess using the AI program. The main measurement is the rate of agreement between the AI's predicted results and the actual culture findings on the first day. The study is sponsored by GramEye and will continue until August 2028. Participants are not subjected to additional procedures beyond standard clinical testing.
CONDITIONS
Brief Title
Development and Evaluation of AI Program for Predicting Bacterial Species From Urine Gram Stain Specimens
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Specimens for which urine culture and urine Gram staining tests were performed for clinical purposes
You will not qualify if you...
- Samples for which suspension of use has been requested
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants provide urine specimens that undergo Gram staining and urine culture for clinical purposes. These specimens are used to evaluate the AI program's predictions.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan, 1608582
Actively Recruiting
Research Team
T
Tatsuya Yamada, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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