Actively Recruiting
Development and Accuracy Evaluation of Gram Staining Analysis AI
Led by GramEye · Updated on 2024-04-22
18000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are developing and evaluating an AI system designed to analyze Gram-stained specimens from clinical settings. This AI aims to improve the accuracy of Gram staining analysis, which is used in diagnosing bacterial infections. The study is observational and focuses on assessing the AI's performance at different accuracy levels. The study involves collecting Gram-stained specimens without any additional intervention from participants. These specimens are then used to develop and test the AI's ability to accurately analyze blood culture Gram stains. There are no treatment groups or placebo controls since the study is observational. Participants who had a Gram stain test ordered as part of their clinical care provide specimens for this study. Researchers measure the AI's accuracy in analyzing these specimens at both advanced and ordinary levels on the first day of analysis. The study does not involve follow-up treatments or interventions, and participation mainly includes allowing use of existing clinical test specimens. The study is expected to continue until March 2027.
CONDITIONS
Brief Title
Development and Accuracy Evaluation of Gram Staining Analysis AI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients in whom a Gram stain test was ordered
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
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.
1 visit (in-person)
Duration - 1 day
Participants provide specimens for development of Gram Stain analysis AI without receiving any intervention.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Osaka University Hospital
Suita, Osaka, Japan, 5650871
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
1
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