[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Labplus Sp. z o.o.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":52},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100655209","clinical-validation-of-an-artificial-intelligence-system-for-the-interpretation-of-laboratory-test-results-combined-with-a-structured-medical-history-100655209",false,"NCT07810491","Clinical Validation of an Artificial Intelligence System for the Interpretation of Laboratory Test Results Combined With a Structured Medical History","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","LTC-VALID","Inclusion Criteria:\n\n* Treated at one of the two participating clinical centers of the Medical University of Silesia\n* Age 18 years or older and under 80 years\n* Presence of symptoms justifying the initiation of a diagnostic work-up\n* Meets the criteria for ordering at least one of the 29 specialist laboratory panels included in the study\n* Able to complete an electronic questionnaire in Polish independently, using a smartphone or a personal computer\n* Holds a Polish national identification number (PESEL)\n* Written informed consent covering all three components of the study\n\nExclusion Criteria:\n\n* Pregnancy\n* Age 80 years or older\n* Inability to provide informed consent, including cognitive impairment or a language barrier\n* Participation in another clinical study that could affect the results\n* Refusal of consent to any of the three components of the study","ALL","18 Years","79 Years",{"count":21,"type":22},899,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.\n\nThe 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.\n\nAdults 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.\n\nThe 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.\n\nThe 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.",[28,29,30],"Diagnostic Techniques and Procedures","Clinical Laboratory Techniques","Triage",[32,33,34,35,36,37,38],"clinical decision support","laboratory medicine","triage","artificial intelligence","diagnostic accuracy","patient-facing communication","medical device software","NOT_YET_RECRUITING","2026-09-03",{"date":42,"type":43},"2026-09-09","ACTUAL",{"date":45,"type":22},"2026-08-19",{"date":47,"type":22},"2027-12-31",{"name":49,"class":50},"Labplus Sp. z o.o.","INDUSTRY",2,""]