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

August 13, 2024 updated by: GramEye
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Tokyo
      • Shinjuku-Ku, Tokyo, Japan, 1608582
        • Recruiting
        • Keio University Hospital
        • Contact:
          • Yoshifumi Uwamino, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Specimens that have undergone urine culture and urine Gram staining for clinical purposes will be included.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GramEye

Collaborators

Keio University
Kameda Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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