Abnormalities in the Blood Test ResultsLTC-AINCT05813938
Assessment of Accuracy and Safety of LabTest Checker
A study testing LabTest Checker in people with Abnormalities in the Blood Test Results, run by Labplus Sp. z o.o. at 1 site in Poland.
Trial summary
The goal of this study is to assess performance of a new clinical decision support system named LabTest Checker in a cohort of adult patients reporting to the internal ward's emergency department. The main question it aims to answer is: how accurate and safe is LabTest Checker. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abnormalities in the Blood Test Results
- What is being tested?
- LabTest Checker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 sitePoland
- Study dates
- 22 Dec 2022to 31 Mar 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult
- requires laboratory test investigation
Who cannot join
- under 18 years old
- pregnant
- no need for laboratory test investigation
Trial locations and contacts
1 site in 1 country.
Poland1 site
Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-027
About this study
Official title: Assessment of Accuracy and Safety of LabTest Checker - Clinical Evaluation of a Patient-centered Clinical Decision Support System Based on AI
The goal of this study is to assess performance of a new clinical decision support system named LabTest Checker in a cohort of adult patients reporting to the internal ward's emergency department. The main question it aims to answer is:
- how accurate and safe is LabTest Checker.
A set of blood laboratory tests will be ordered for each participant. Participants will use LabTest Checker to obtain an interpretation of their test results. The interpretation provided by LabTest Checker will then be compared with the interpretation given by an internal medicine specialist to assess the accuracy and safety of the tool.
- Conditions
- Abnormalities in the Blood Test Results
- Being tested
- LabTest Checker
- Keywords
- laboratory test interpretation, artificial intelligence, clinical decision support system, clinical implementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabTest CheckerDevice
A set of blood laboratory tests is ordered. Test results are recorded in the LabTest Checker. LabTest Checker's diagnostic engine automatically generates a personalized questionnaire that is filled out by the patient. After obtaining all necessary information, including the patient's chronic diseases, medications taken, and symptoms, the tool presents an interpretation of test results.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Not described Receives: Device: LabTest Checker |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy
the ratio of the number of patients for whom the LTC correctly assigned triage category to the total number of patients
Measured: 7 days
sensivity to emergency
the ratio of the number of cases correctly identified as emergency by the LTC to the number of cases identified as emergency by the physician
Measured: 7 days
sensivity to urgency
the ratio of the number of cases correctly identified as urgency by the LTC to the number of cases identified as urgency by the physician
Measured: 7 days
safety
the ratio of the number of patients for whom a triage category assigned by the LTC was higher than or equal to the triage category assigned by the physician to the total number of cases
Measured: 7 days
Secondary outcomes (1)
reduction of unnecessary visits
the ratio of the number of patients who will avoid at least one unnecessary consultation by following the LabTest Checkers recommendations to the total number of patients
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start22 Dec 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormalities in the Blood Test ResultsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Labplus Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813938
- Sponsor's protocol ID
- LP001
- Acronym
- LTC-AI
- Status last verified
- Apr 2023
- First submitted
- 3 Apr 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Accuracy and Safety of LabTest Checker - Clinical Evaluation of a Patient-centered Clinical Decision Support System Based on AI
- ClinicalTrials.gov ID
- NCT05813938
- Acronym / sponsor ID
- LTC-AI / LP001
- Conditions
- Abnormalities in the Blood Test Results
- Keywords
- laboratory test interpretation, artificial intelligence, clinical decision support system, clinical implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Labplus Sp. z o.o.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 14 Apr 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 goal of this study is to assess performance of a new clinical decision support system named LabTest Checker in a cohort of adult patients reporting to the internal ward's emergency department. The main question it aims to answer is:
- how accurate and safe is LabTest Checker.
A set of blood laboratory tests will be ordered for each participant. Participants will use LabTest Checker to obtain an interpretation of their test results. The interpretation provided by LabTest Checker will then be compared with the interpretation given by an internal medicine specialist to assess the accuracy and safety of the tool.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: LabTest Checker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult
- requires laboratory test investigation
Key exclusion criteria (3 listed)
- under 18 years old
- pregnant
- no need for laboratory test investigation
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 |
|---|---|---|
| LabTest CheckerA set of blood laboratory tests is ordered. Test results are recorded in the LabTest Checker. LabTest Checker's diagnostic engine automatically generates a personalized questionnaire that is filled out by the patient. After obtaining all necessary information, including the patient's chronic diseases, medications taken, and symptoms, the tool presents an interpretation of test results. | Device | Intervention arm |
Primary outcome
accuracy
Time frame: 7 days
the ratio of the number of patients for whom the LTC correctly assigned triage category to the total number of patients
sensivity to emergency
Time frame: 7 days
the ratio of the number of cases correctly identified as emergency by the LTC to the number of cases identified as emergency by the physician
sensivity to urgency
Time frame: 7 days
the ratio of the number of cases correctly identified as urgency by the LTC to the number of cases identified as urgency by the physician
safety
Time frame: 7 days
the ratio of the number of patients for whom a triage category assigned by the LTC was higher than or equal to the triage category assigned by the physician to the total number of cases
1 secondary outcome
reduction of unnecessary visits
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LabTest Checker in people with Abnormalities in the Blood Test Results, run by Labplus Sp. z o.o. at 1 site in Poland.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy (time frame: 7 days). The study lists 4 primary outcomes in all. 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 14 Apr 2023.