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

NCT ID: NCT06554145

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-25

Study Completion Date

2028-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bacterial Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keio University

OTHER

Sponsor Role collaborator

Kameda Medical Center

OTHER

Sponsor Role collaborator

GramEye

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Keio University Hospital

Shinjuku-Ku, Tokyo, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Tatsuya Yamada, M.D.

Role: CONTACT

7028060149

Facility Contacts

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Yoshifumi Uwamino, MD PhD

Role: primary

Other Identifiers

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GE003

Identifier Type: -

Identifier Source: org_study_id

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