Development and Accuracy Evaluation of Gram Staining Analysis AI

NCT ID: NCT06377592

Last Updated: 2024-04-22

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

18000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-10

Study Completion Date

2027-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Groups providing specimens for development of Gram Stain analysis AI

Sample collection without intervention

Intervention Type OTHER

No Intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sample collection without intervention

No Intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients in whom a Gram stain test was ordered
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GramEye

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Satoshi Kutsuna, PhD, MD

Role: STUDY_DIRECTOR

Osaka University Medical Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Osaka University Hospital

Suita, Osaka, Japan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Japan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tatsuya Yamada, M.D.

Role: CONTACT

7028060149

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Go Yamamoto

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

G22396

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.