Actively Recruiting

All Genders
ID06519032

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

Led by GramEye · Updated on 2024-07-26

10000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

G

GramEye

Lead Sponsor

O

Osaka University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This observational study aims to develop artificial intelligence (AI) technology that can detect and classify Acid-Fast Bacilli (AFB) in microscope images. The AI will be trained and evaluated using anonymized and fixed glass slides to improve rapid bacterial species identification related to bacterial infections. The research is sponsored by GramEye and focuses on enhancing diagnostic accuracy for these infections. The study does not involve treatments or interventions but collects microscope images of AFB smears to develop and assess the AI system. There are no study groups or drug therapies involved. The AI's performance will be compared to actual culture results to measure agreement in detecting the presence or absence of acid-fast bacteria. Participants are patients who have had an AFB smear test ordered. Researchers will analyze microscope images from these patients without impacting their usual care. The main outcome measured is how well the AI's results match actual culture findings on day one. There are no additional tests or follow-ups required, and participation involves only data collection from existing samples.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients in whom acid-fast bacilli(AFB) smear test was ordered
Not Eligible

You will not qualify if you...

  • No exclusion criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo acid-fast bacilli smear tests and AI-based image analysis to identify bacterial species.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 6 months

Participants are observed to compare AI-estimated results with actual culture results regarding the presence or absence of acid-fast bacteria.

Additional visits as needed for culture results

Trial Site Locations

Total: 1 location

1

Osaka University Hospital

Suita, Osaka, Japan, 5650871

Actively Recruiting

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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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