Diagnostic Techniques and ProceduresLTC-VALIDNCT07810491
Clinical Validation of an Artificial Intelligence System for the Interpretation of Laboratory Test Results Combined With a Structured Medical History
A study testing AI-based laboratory result interpretation software in people with Diagnostic Techniques and Procedures and Clinical Laboratory Techniques, run by Labplus Sp. z o.o. at 2 sites in Poland.
Trial summary
This study evaluates a certified artificial intelligence (AI) based software system that automatically interprets laboratory test results in combination with a structured, dynamically generated medical history questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diagnostic Techniques and Procedures, Clinical Laboratory Techniques, Triage
- What is being tested?
- AI-based laboratory result interpretation software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 899 participants
- Where
- 2 sitesPoland
- Study dates
- 19 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated at one of the two participating clinical centers of the Medical University of Silesia
- Age 18 years or older and under 80 years
- Presence of symptoms justifying the initiation of a diagnostic work-up
- Meets the criteria for ordering at least one of the 29 specialist laboratory panels included in the study
- Able to complete an electronic questionnaire in Polish independently, using a smartphone or a personal computer
- Holds a Polish national identification number (PESEL)
- Written informed consent covering all three components of the study
Who cannot join
- Pregnancy
- Age 80 years or older
- Inability to provide informed consent, including cognitive impairment or a language barrier
- Participation in another clinical study that could affect the results
- Refusal of consent to any of the three components of the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites
Independent Public Clinical Hospital named after Andrzej Mielecki, Medical University of Silesia
Katowice
Jerzy Chudek, +48322591202, clinicaltrials@labplus.pl
Prof. K. Gibinski University Clinical Center, Medical University of Silesia
Katowice
Michal Holecki, MD, PhD, +48322591202, clinicaltrials@labplus.pl
About this study
Official title: Telemedicine Technology Supporting the Diagnostic Process Based on Automated Analysis of Laboratory Test Results With a Structured Medical History: A Prospective, Two-Center, Two-Phase Clinical Validation Study
This study evaluates a certified artificial intelligence (AI) based software system that automatically interprets laboratory test results in combination with a structured, dynamically generated medical history questionnaire.
The purpose of the study is to determine how accurately and how safely the system assigns a patient to a category of urgency of medical contact, and how closely the interpretations produced by the system correspond to the assessment of an expert physician.
Read more
Adults treated at two university hospitals in Katowice, Poland, who are referred for laboratory testing, complete an electronic medical history questionnaire after their laboratory results become available. The system then generates an interpretation for each laboratory result, including a category of urgency of medical contact, a suggested medical specialty and suggested further laboratory tests. The attending physician independently records a clinical assessment of the same laboratory results and medical history without access to the output of the system. An independent expert physician subsequently establishes the reference assessment, blinded to the authorship of the assessments being compared. The interpretation report is released to the participant only after the assessment of the attending physician has been recorded and locked.
The study is conducted in two phases. The first phase (609 participants) is exploratory and uses the initial version of the system. The second phase (290 participants) is confirmatory and uses the final, frozen version of the system. All outcome measures are assessed in both phases; the pre-specified confirmatory hypothesis test applies to the second phase.
The endpoints of this study are properties of the software system, namely the concordance of its output with an expert reference assessment. Health outcomes of participants are not measured.
Read the detailed description
Design. LTC-VALID is a prospective, two-center, single-arm, two-phase clinical validation study of a CE-marked class IIa medical device software intended for the automated interpretation of laboratory test results.
Phase structure. Phase I (609 participants, months 1 to 9) is exploratory and serves algorithm development and gap identification using version 1.0 of the software. An interposed optimization stage (months 9 to 10) produces a frozen version 2.0. Phase II (290 participants, months 11 to 13) is confirmatory. All outcome measures listed below are collected identically in both phases and are reported separately by phase. Results from the two phases are not pooled, because the two phases evaluate different versions of the software. The pre-specified confirmatory hypothesis test for the co-primary measures is applied to Phase II data; Phase I results for the same measures are exploratory and are reported descriptively.
Procedures. Eligible participants provide written informed consent, are referred for a mandatory basic laboratory panel and one or two of 29 specialist laboratory panels, and provide a single blood draw at a certified laboratory collection point. After the results become available, the participant completes a dynamically generated electronic medical history questionnaire. The software produces one interpretation per laboratory result; interpretations are not aggregated by the software. The attending physician records an independent clinical assessment of the same data while blinded to the software output; this assessment is locked before the interpretation report is released to the participant. Participants complete a questionnaire evaluating the report, and physicians complete a form evaluating the completeness and relevance of the automated medical history.
Reference standard and comparators. An independent expert physician receives the complete documentation and establishes an own reference assessment before reviewing the assessments to be compared. The assessments of the software, of the attending physician and of large language models are presented in random order and blinded as to authorship. The comparators are comparators of assessment, not study arms; the study is single-arm and no randomization or control group is used.
Reporting standard. The primary analysis follows the Standards for Reporting of Diagnostic Accuracy Studies (STARD). The study is a diagnostic accuracy study and not a study of clinical effectiveness.
Statistical approach. The two primary outcome measures are co-primary and are evaluated using an intersection-union test; both must meet their pre-specified criteria. The pre-specified criteria apply to Phase II: for the safety measure, the lower bound of the one-sided 95 percent confidence interval is at or above 95 percent; for the accuracy measure, at or above 90 percent. Confidence intervals for proportions are calculated using exact methods (Clopper-Pearson). Phase I is exploratory and its data are reported descriptively. Sensitivity for the rare urgency categories is reported with confidence intervals and event counts as a secondary, non-confirmatory measure, because its denominator is not sufficient for formal hypothesis testing at the planned sample size.
- Being tested
- AI-based laboratory result interpretation software
- Keywords
- clinical decision support, laboratory medicine, triage, artificial intelligence, diagnostic accuracy, patient-facing communication, medical device software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based laboratory result interpretation softwareDiagnostic test
Also called LabTest Checker
A CE-marked class IIa medical device software for the automated interpretation of laboratory test results, operated within its intended purpose. The software administers a structured medical history questionnaire in which subsequent questions are selected dynamically on the basis of the laboratory results and of previous answers. For each laboratory result the software generates one interpretation, comprising a category of urgency of medical contact (immediate, urgent, routine, or no need for medical contact), a suggested medical specialty, a list of suggested further laboratory tests, and an explanatory text addressed to the patient. Interpretations are not aggregated by the software. The interpretation report is generated once per participant, after completion of the questionnaire, and is released to the participant after the assessment of the attending physician has been recorded and locked. The generated report is not used to direct the clinical management of the participant.
| Study group | Role | What they receive |
|---|---|---|
| AI-Based Interpretation of Laboratory Test Results | Experimental | Single arm. All participants complete an electronic, dynamically generated medical history questionnaire administered by the software after their laboratory results become available, and subsequently receive a software-generated interpretation report. The report is released to the participant only after the independent clinical assessment of the attending physician has been recorded and locked. No control group is used. The assessments of the attending physician, of an independent expert physician and of large language models are comparators of assessment and do not constitute study arms. Receives: Diagnostic Test: AI-based laboratory result interpretation software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants for Whom the Urgency Category Assigned by the Software Was Not Lower Than the Category Assigned by the Expert Physician (Patient Triage Safety Indicator)
The urgency category assigned by the software is compared with the urgency category assigned by an expert physician serving as the reference standard. The urgency categories, ordered from highest to lowest, are: immediate medical contact, urgent medical contact, routine medical contact, and no need for medical contact. A participant is counted in the numerator when the category assigned by the software is the same as or higher than the category assigned by the expert physician. The measure is the percentage of participants counted in the numerator. Range: 0 to 100 percent; higher values indicate better performance. The measure is assessed separately in each study phase and data from the two phases are not combined. Each comparison is based on data locked at the time of enrollment; the expert assessment is performed retrospectively, in batches, on a locked dataset, and the calendar timing of the batch review does not affect the measured quantity.
Measured: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Percentage of Participants for Whom the Urgency Category Assigned by the Software Was Identical to the Category Assigned by the Expert Physician (Patient Triage Accuracy)
The urgency category assigned by the software is compared with the urgency category assigned by an expert physician serving as the reference standard. The urgency categories, ordered from highest to lowest, are: immediate medical contact, urgent medical contact, routine medical contact, and no need for medical contact. A participant is counted in the numerator when the category assigned by the software is identical to the category assigned by the expert physician. The measure is the percentage of participants counted in the numerator. Range: 0 to 100 percent; higher values indicate better performance. The measure is assessed separately in each study phase and data from the two phases are not combined. Each comparison is based on data locked at the time of enrollment; the expert assessment is performed retrospectively, in batches, on a locked dataset, and the calendar timing of the batch review does not affect the measured quantity.
Measured: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Secondary outcomes (8)
Sensitivity for the Immediate Medical Contact Category
Proportion of participants assigned by the expert physician to the immediate medical contact category who were assigned to the same category by the software. Range: 0 to 100 percent; higher values indicate better performance. Reported with a 95 percent confidence interval and the number of events. No formal hypothesis test is performed, because the expected denominator at the planned sample size is not sufficient for confirmatory testing. Assessed separately in both study phases.
Measured: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Sensitivity for the Urgent Medical Contact Category
Proportion of participants assigned by the expert physician to the urgent medical contact category who were assigned to the same category by the software. Range: 0 to 100 percent; higher values indicate better performance. Reported with a 95 percent confidence interval and the number of events. No formal hypothesis test is performed, because the expected denominator at the planned sample size is not sufficient for confirmatory testing. Assessed separately in both study phases.
Measured: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Agreement on Urgency Category Measured by Quadratic Weighted Cohen's Kappa
Agreement between the urgency category assigned by the software and by the expert physician, expressed as Cohen's kappa with quadratic weights applied to the four ordered urgency categories. Range: -1 to 1; higher values indicate better agreement. Reported with a 95 percent confidence interval. Supplementary to the co-primary measure of accuracy. Assessed separately in both study phases.
Measured: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Per-Result Concordance on Recommended Medical Specialty
Concordance between the medical specialty recommended by the software and by the expert physician, evaluated at the level of a single laboratory result. Reported as precision and macro-averaged recall. Range: 0 to 1; higher values indicate better performance. Assessed separately in both study phases.
Measured: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Per-Result Concordance on Recommended Additional Laboratory Tests
Concordance between the additional laboratory tests recommended by the software and by the expert physician, evaluated at the level of a single laboratory result. Reported as precision and macro-averaged recall. Range: 0 to 1; higher values indicate better performance. Assessed separately in both study phases.
Measured: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Comparative Concordance of the Software, the Attending Physician and Large Language Models Against the Reference Standard
Concordance of three sources of assessment - the software, the attending physician and large language models - with the same expert reference assessment, using the measures defined above. Assessments are compared retrospectively on a locked dataset. Reported descriptively for each source; no ranking test is performed.
Measured: Months 15 to 18 after study start
Proportion of Participants Rating the Interpretation Report as Comprehensible
Proportion of participants who, in a study-specific questionnaire completed after release of the interpretation report, indicate that the content of the report was comprehensible. Range: 0 to 100 percent; higher values indicate better performance. Assessed separately in both study phases.
Measured: Immediately after release of the report
Proportion of Automated Medical History Records Assessed by the Attending Physician as Complete and Relevant
Proportion of automated medical history records for which the attending physician reports no objections regarding completeness or relevance, recorded in a study-specific form. Range: 0 to 100 percent; higher values indicate better performance. Assessed separately in both study phases.
Measured: Immediately after the assessment of the attending physician
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start19 Aug 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diagnostic Techniques and ProceduresStudies 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
- 899 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Labplus Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Silesia in Katowice
- Responsible party
- Sponsor
- Investigators
- Jerzy Chudek, MD, PhD, Principal investigator, Medical University of Silesia in Katowice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810491
- Sponsor's protocol ID
- LP004
- Other IDs
- FEDS.01.02-IP.01-0078/24, BNW/NWN/0052/KB1/34/26
- Acronym
- LTC-VALID
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The study protocol and the statistical analysis plan may be made available with the primary publication. Individual-level data are subject to trade secret protection and are not covered by the scope of participant consent for redistribution.
Publications
Szumilas D, Ochmann A, Zieba K, Bartoszewicz B, Kubrak A, Makuch S, Agrawal S, Mazur G, Chudek J. Evaluation of AI-Driven LabTest Checker for Diagnostic Accuracy and Safety: Prospective Cohort Study. JMIR Med Inform. 2024 Aug 14;12:e57162. doi: 10.2196/57162.
PubMed 39149851
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Technology Supporting the Diagnostic Process Based on Automated Analysis of Laboratory Test Results With a Structured Medical History: A Prospective, Two-Center, Two-Phase Clinical Validation Study
- ClinicalTrials.gov ID
- NCT07810491
- Acronym / sponsor ID
- LTC-VALID / LP004
- Keywords
- clinical decision support, laboratory medicine, triage, artificial intelligence, diagnostic accuracy, patient-facing communication, medical device software
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 899 participants (estimated)
- Lead sponsor
- Labplus Sp. z o.o.Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Silesia in Katowice
- Study start
- 19 Aug 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Sep 2026 (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.
This study evaluates a certified artificial intelligence (AI) based software system that automatically interprets laboratory test results in combination with a structured, dynamically generated medical history questionnaire.
The purpose of the study is to determine how accurately and how safely the system assigns a patient to a category of urgency of medical contact, and how closely the interpretations produced by the system correspond to the assessment of an expert physician.
Adults treated at two university hospitals in Katowice, Poland, who are referred for laboratory testing, complete an electronic medical history questionnaire after their laboratory results become available. The system then generates an interpretation for each laboratory result, including a category of urgency of medical contact, a suggested medical specialty and suggested further laboratory tests. The attending physician independently records a clinical assessment of the same laboratory results and medical history without access to the output of the system. An independent expert physician subsequently establishes the reference assessment, blinded to the authorship of the assessments being compared. The interpretation report is released to the participant only after the assessment of the attending physician has been recorded and locked.
The study is conducted in two phases. The first phase (609 participants) is exploratory and uses the initial version of the system. The second phase (290 participants) is confirmatory and uses the final, frozen version of the system. All outcome measures are assessed in both phases; the pre-specified confirmatory hypothesis test applies to the second phase.
The endpoints of this study are properties of the software system, namely the concordance of its output with an expert reference assessment. Health outcomes of participants are not measured.
Detailed description
Design. LTC-VALID is a prospective, two-center, single-arm, two-phase clinical validation study of a CE-marked class IIa medical device software intended for the automated interpretation of laboratory test results.
Phase structure. Phase I (609 participants, months 1 to 9) is exploratory and serves algorithm development and gap identification using version 1.0 of the software. An interposed optimization stage (months 9 to 10) produces a frozen version 2.0. Phase II (290 participants, months 11 to 13) is confirmatory. All outcome measures listed below are collected identically in both phases and are reported separately by phase. Results from the two phases are not pooled, because the two phases evaluate different versions of the software. The pre-specified confirmatory hypothesis test for the co-primary measures is applied to Phase II data; Phase I results for the same measures are exploratory and are reported descriptively.
Procedures. Eligible participants provide written informed consent, are referred for a mandatory basic laboratory panel and one or two of 29 specialist laboratory panels, and provide a single blood draw at a certified laboratory collection point. After the results become available, the participant completes a dynamically generated electronic medical history questionnaire. The software produces one interpretation per laboratory result; interpretations are not aggregated by the software. The attending physician records an independent clinical assessment of the same data while blinded to the software output; this assessment is locked before the interpretation report is released to the participant. Participants complete a questionnaire evaluating the report, and physicians complete a form evaluating the completeness and relevance of the automated medical history.
Reference standard and comparators. An independent expert physician receives the complete documentation and establishes an own reference assessment before reviewing the assessments to be compared. The assessments of the software, of the attending physician and of large language models are presented in random order and blinded as to authorship. The comparators are comparators of assessment, not study arms; the study is single-arm and no randomization or control group is used.
Reporting standard. The primary analysis follows the Standards for Reporting of Diagnostic Accuracy Studies (STARD). The study is a diagnostic accuracy study and not a study of clinical effectiveness.
Statistical approach. The two primary outcome measures are co-primary and are evaluated using an intersection-union test; both must meet their pre-specified criteria. The pre-specified criteria apply to Phase II: for the safety measure, the lower bound of the one-sided 95 percent confidence interval is at or above 95 percent; for the accuracy measure, at or above 90 percent. Confidence intervals for proportions are calculated using exact methods (Clopper-Pearson). Phase I is exploratory and its data are reported descriptively. Sensitivity for the rare urgency categories is reported with confidence intervals and event counts as a secondary, non-confirmatory measure, because its denominator is not sufficient for formal hypothesis testing at the planned sample size.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AI-Based Interpretation of Laboratory Test Results | Experimental | Diagnostic Test: AI-based laboratory result interpretation softwareSingle arm. All participants complete an electronic, dynamically generated medical history questionnaire administered by the software after their laboratory results become available, and subsequently receive a software-generated interpretation report. The report is released to the participant only after the independent clinical assessment of the attending physician has been recorded and locked. No control group is used. The assessments of the attending physician, of an independent expert physician and of large language models are comparators of assessment and do not constitute study arms. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Treated at one of the two participating clinical centers of the Medical University of Silesia
- Age 18 years or older and under 80 years
- Presence of symptoms justifying the initiation of a diagnostic work-up
- Meets the criteria for ordering at least one of the 29 specialist laboratory panels included in the study
- Able to complete an electronic questionnaire in Polish independently, using a smartphone or a personal computer
Key exclusion criteria (5 listed)
- Pregnancy
- Age 80 years or older
- Inability to provide informed consent, including cognitive impairment or a language barrier
- Participation in another clinical study that could affect the results
- Refusal of consent to any of the three components of the study
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 |
|---|---|---|
| AI-based laboratory result interpretation softwareAlso: LabTest CheckerA CE-marked class IIa medical device software for the automated interpretation of laboratory test results, operated within its intended purpose. The software administers a structured medical history questionnaire in which subsequent questions are selected dynamically on the basis of the laboratory results and of previous answers. For each laboratory result the software generates one interpretation, comprising a category of urgency of medical contact (immediate, urgent, routine, or no need for medical contact), a suggested medical specialty, a list of suggested further laboratory tests, and an explanatory text addressed to the patient. Interpretations are not aggregated by the software. The interpretation report is generated once per participant, after completion of the questionnaire, and is released to the participant after the assessment of the attending physician has been recorded and locked. The generated report is not used to direct the clinical management of the participant. | Diagnostic test | AI-Based Interpretation of Laboratory Test Results |
Primary outcome
Percentage of Participants for Whom the Urgency Category Assigned by the Software Was Not Lower Than the Category Assigned by the Expert Physician (Patient Triage Safety Indicator)
Time frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
The urgency category assigned by the software is compared with the urgency category assigned by an expert physician serving as the reference standard. The urgency categories, ordered from highest to lowest, are: immediate medical contact, urgent medical contact, routine medical contact, and no need for medical contact. A participant is counted in the numerator when the category assigned by the software is the same as or higher than the category assigned by the expert physician. The measure is the percentage of participants counted in the numerator. Range: 0 to 100 percent; higher values indicate better performance. The measure is assessed separately in each study phase and data from the two phases are not combined. Each comparison is based on data locked at the time of enrollment; the expert assessment is performed retrospectively, in batches, on a locked dataset, and the calendar timing of the batch review does not affect the measured quantity.
Percentage of Participants for Whom the Urgency Category Assigned by the Software Was Identical to the Category Assigned by the Expert Physician (Patient Triage Accuracy)
Time frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
The urgency category assigned by the software is compared with the urgency category assigned by an expert physician serving as the reference standard. The urgency categories, ordered from highest to lowest, are: immediate medical contact, urgent medical contact, routine medical contact, and no need for medical contact. A participant is counted in the numerator when the category assigned by the software is identical to the category assigned by the expert physician. The measure is the percentage of participants counted in the numerator. Range: 0 to 100 percent; higher values indicate better performance. The measure is assessed separately in each study phase and data from the two phases are not combined. Each comparison is based on data locked at the time of enrollment; the expert assessment is performed retrospectively, in batches, on a locked dataset, and the calendar timing of the batch review does not affect the measured quantity.
8 secondary outcomes
Sensitivity for the Immediate Medical Contact Category
Time frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Sensitivity for the Urgent Medical Contact Category
Time frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Agreement on Urgency Category Measured by Quadratic Weighted Cohen's Kappa
Time frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Per-Result Concordance on Recommended Medical Specialty
Time frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Per-Result Concordance on Recommended Additional Laboratory Tests
Time frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start
Comparative Concordance of the Software, the Attending Physician and Large Language Models Against the Reference Standard
Time frame: Months 15 to 18 after study start
Proportion of Participants Rating the Interpretation Report as Comprehensible
Time frame: Immediately after release of the report
Proportion of Automated Medical History Records Assessed by the Attending Physician as Complete and Relevant
Time frame: Immediately after the assessment of the attending physician
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Results publication: PubMed 39149851Szumilas D, Ochmann A, Zieba K, Bartoszewicz B, Kubrak A, Makuch S, Agrawal S, Mazur G, Chudek J. Evaluation of AI-Driven LabTest Checker for Diagnostic Accuracy and Safety: Prospective Cohort Study. JMIR Med Inform. 2024 Aug 14;12:e57162. doi: 10.2196/57162.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The study protocol and the statistical analysis plan may be made available with the primary publication. Individual-level data are subject to trade secret protection and are not covered by the scope of participant consent for redistribution.
Related trials for Diagnostic Techniques and Procedures
Recruiting
Choose Myself (Before) Losing Myself
Dementia (Diagnosis), Mild Cognitive Impairment
RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
Not yet recruiting
Efficacy and Safety of Nasopharyngeal Tube During Sedation
Sedation in Non-intubated Diagnostic and Therapeutic Procedures, Sedation
RecruitingPhase 3
Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution
ENT Disorder, Nasal Procedures
RecruitingObservational study
Diagnostic Innovations for Pediatric Tuberculosis in Bolivia
Tuberculosis
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.
Jerzy Chudek, MD, PhD principal investigator
Medical University of Silesia in Katowice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based laboratory result interpretation software in people with Diagnostic Techniques and Procedures and Clinical Laboratory Techniques, run by Labplus Sp. z o.o. at 2 sites 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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jerzy Chudek, MD, PhD (+48322591202, clinicaltrials@labplus.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants for Whom the Urgency Category Assigned by the Software Was Not Lower Than the Category Assigned by the Expert Physician (Patient Triage Safety Indicator) (time frame: Through completion of the expert reference assessment for all enrolled participants, up to 16 months after study start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07810491, which also lists 1 linked publication.
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 9 Sep 2026.