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Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device

NCT06143657 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1600

Last updated 2023-12-06

No results posted yet for this study

Summary

The investigators have developed an analysis AI for Gram staining. In this study, the investigators will compare the testing accuracy of automated Gram staining equipment with AI with the testing accuracy of laboratory technicians. Based on the results, the investigators will examine the possibility of clinical application of the automated Gram staining device.

Conditions

  • Infection, Bacterial

Interventions

DIAGNOSTIC_TEST

Automated Gram Staining Machine analysis

Measure urine and sputum specimens using this device.

Sponsors & Collaborators

  • GramEye

    lead INDUSTRY

Principal Investigators

  • Yoshifumi UwaminoUwamino, Ph.D. · Assistant professor, Keio University hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-10
Primary Completion
2024-06-30
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06143657 on ClinicalTrials.gov