Infection, BacterialNCT06143657
Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device
An observational study of Infection, Bacterial, run by GramEye.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- Automated Gram Staining Machine analysis
- How many people
- 1,600 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Specimens for microbiological testing, such as Gram staining, ordered at the hospital providing the specimens.
Who may be able to join
- 1. Patients in whom a Gram stain test was ordered
Who cannot join
- No exclusion criteria
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Gram staining,whitch provides crucial information for selecting antibiotics in the diagnosis and treatment of infectious diseases, is often manually performed in many laboratories, and the microscopic findings are subjectively interpreted and reported based on the experience of laboratory technicians. Automating the entire process from staining to microscopic examination, as achieved by the AI-equipped automatic Gram staining device, can reduce the labor required for Gram staining. This automation enables even less experienced technicians to quickly report Gram staining results.
The aim of this study is to evaluate the accuracy of the Auto microscopic examination of Gram-stained samples using anonymized processed slides created from clinical specimens. This evaluation will be compared with the accuracy of microscopic examinations performed by hospital laboratory technicians.
If the accuracy of the machine is demonstrated, it can be registered as a medical device and proceed to the implementation stage in actual clinical settings. The implementation of this device in clinical laboratories is expected to reduce workload, expedite processes, and contribute to the optimization of antibiotic use based on Gram staining results.
- Conditions
- Infection, Bacterial
- Being tested
- Automated Gram Staining Machine analysis
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Gram Staining Machine analysisDiagnostic test
Measure urine and sputum specimens using this device.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
The difference in accuracy rates between the Gram staining examination performed by laboratory technicians and the automated Gram staining device, including the approximate bacterial quantity based on Gram staining and morphology (categorized as -, 1+, 2+, 3+, 4+), presence of white blood cells, presence of phagocytic images, and, in the case of sputum, the Geckler classification.
Measured: Day 1
Secondary outcomes (1)
Secondary Outcome
Impact of specimen type and identified bacterial species on testing accuracy.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start10 Jan 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GramEye
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoshifumi UwaminoUwamino, Ph.D., Principal investigator, Assistant professor, Keio University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143657
- Sponsor's protocol ID
- K22581
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device
- ClinicalTrials.gov ID
- NCT06143657
- Acronym / sponsor ID
- K22581
- Conditions
- Infection, Bacterial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- GramEyeIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Gram staining,whitch provides crucial information for selecting antibiotics in the diagnosis and treatment of infectious diseases, is often manually performed in many laboratories, and the microscopic findings are subjectively interpreted and reported based on the experience of laboratory technicians. Automating the entire process from staining to microscopic examination, as achieved by the AI-equipped automatic Gram staining device, can reduce the labor required for Gram staining. This automation enables even less experienced technicians to quickly report Gram staining results.
The aim of this study is to evaluate the accuracy of the Auto microscopic examination of Gram-stained samples using anonymized processed slides created from clinical specimens. This evaluation will be compared with the accuracy of microscopic examinations performed by hospital laboratory technicians.
If the accuracy of the machine is demonstrated, it can be registered as a medical device and proceed to the implementation stage in actual clinical settings. The implementation of this device in clinical laboratories is expected to reduce workload, expedite processes, and contribute to the optimization of antibiotic use based on Gram staining results.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Specimens for microbiological testing, such as Gram staining, ordered at the hospital providing the specimens.
Key inclusion criteria (1 listed)
- 1. Patients in whom a Gram stain test was ordered
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated Gram Staining Machine analysisMeasure urine and sputum specimens using this device. | Diagnostic test | – |
Primary outcome
Primary Outcome
Time frame: Day 1
The difference in accuracy rates between the Gram staining examination performed by laboratory technicians and the automated Gram staining device, including the approximate bacterial quantity based on Gram staining and morphology (categorized as -, 1+, 2+, 3+, 4+), presence of white blood cells, presence of phagocytic images, and, in the case of sputum, the Geckler classification.
1 secondary outcome
Secondary Outcome
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshifumi UwaminoUwamino, Ph.D. principal investigator
Assistant professor, Keio University hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Bacterial, run by GramEye.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yamada Tatsuya, M.D. (7028060149, tatsuya.yamada@grameye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.