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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

NCT ID NCT07810491

NEW Sponsor: Labplus Sp. z o.o. Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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. 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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 899 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clinical laboratory techniques Diagnostic techniques and procedures TRIAGE

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

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    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Independent Public Clinical Hospital named after Andrzej Mielecki, Medical University of Silesia

    Katowice, Poland

    Contact Email: •••••@•••••

  • Prof. K. Gibinski University Clinical Center, Medical University of Silesia

    Katowice, Poland

    Contact Email: •••••@•••••

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