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NCT Number: NCT06554145

Development and Evaluation of AI Program for Predicting Bacterial Species From Urine Gram Stain Specimens

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.

Recruiting

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Keio University Hospital

Shinjuku-Ku, Tokyo, 1608582, Japan

Location status: Recruiting

Location contact

Yoshifumi Uwamino, MD PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Specimens for which urine culture and urine Gram staining tests were performed for clinical purposes

Exclusion criteria

  • Samples for which suspension of use has been requested

Treatment and study plan

Primary outcomes

  1. Rate of concordance between AI-estimated results with actual culture results regarding urine Gram stain specimens

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tatsuya Yamada, M.D.

CONTACT

[email protected]

7028060149

Sponsors and collaborators

Lead sponsor

GramEye

Industry

Collaborators

  • Kameda Medical Center
  • Keio University

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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