Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-01 @ 7:19 PM
Study NCT ID:
NCT06933550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-18
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREMEDICAL is a Clinical Investigation Aiming to Create a Data Basis That Can be Used to Enrich Information Collected in the Course of the Classic Patient Journey. Patients in the Emergency Department Will be Asked to Answer Patient-related and Symptom-oriented Questions. Minimum Age is 18 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-04-16', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'XUND Symptom Checker', 'timeFrame': 'through investigation completion, an average of 1 year', 'description': "The fundamental element of the proposed project is the aggregation of novel, patient-related and symptom-oriented data on-site and directly from patients in the emergency department. The objective of this study is to establish a novel type of data basis, with the potential to enhance the information collected during the conventional patient journey, including medical history forms and discharge letters. XUND's Symptom Check, which has been certified as a class IIa medical device, will be used to collect the data. Selected patients in the emergency waiting area record their symptoms on a tablet and answer the questions asked. The Symptom Check is powered by an AI-driven medical knowledge base of 520+ conditions and 21,000+ symptom variants."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['XUND', 'emergency department', 'symptom check', 'patient journey'], 'conditions': ['Emergency Department Triage']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical investigation is to create a new type of data basis that can be used to enrich information collected in the course of the classic patient journey, such as medical history forms and discharge letters. Therefore, it is planned to collect new, patient-related and symptom-oriented data on site and directly from patients in the emergency department (female/male; at least 18 years old).\n\nThe main question it aims to answer is:\n\n\\- Can a detailed medical history with additional enriched information from XUND improve the quality of outpatient care?\n\nSelected patients in the waiting area of the emergency department will record their symptoms on a tablet and answer the questions asked about their symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'German speaking, at least 18 years old, all gender patients in the emergency department (triage category 3, 4, or 5).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a signed informed consent form;\n* signed consent and admission to the emergency department of the emergency medicine clinic\n* Triage category 3, 4 or 5 based on the triage procedure according to the Manchester triage system used in Austria\n* the physical and mental ability to operate the tablet and answer the questions\n* 18 years of age or older;\n* knowledge of the German language.\n\nExclusion Criteria:\n\n* not meeting all inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06933550', 'briefTitle': 'PREMEDICAL is a Clinical Investigation Aiming to Create a Data Basis That Can be Used to Enrich Information Collected in the Course of the Classic Patient Journey. Patients in the Emergency Department Will be Asked to Answer Patient-related and Symptom-oriented Questions. Minimum Age is 18 Years', 'organization': {'class': 'INDUSTRY', 'fullName': 'XUND Solutions GmbH'}, 'officialTitle': 'FFG PREMEDICAL (Clinical Investigation of a Medical Device According to MDR Article 82, Para.1 and Austrian Law §13 Para. 3 MPG, BGBI. I No. 122/2021 - Study Without Influence on Diagnostics/Therapy)', 'orgStudyIdInfo': {'id': '892459'}, 'secondaryIdInfos': [{'id': '102478757', 'type': 'OTHER', 'domain': 'BASG/AGES Institute Surveillance'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'contacts': [{'name': 'Lars-Peter Kamolz, Univ.-Prof. Dr.med., MSc', 'role': 'CONTACT', 'email': 'lars.kamolz@medunigraz.at', 'phone': '+43 316 385-14685'}, {'name': 'Lars-Peter Kamolz, Univ.-Prof. Dr.med., MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Lukas Seper', 'role': 'CONTACT', 'email': 'seper@xund.ai', 'phone': '0043 1 9053804 222'}, {'name': 'Pia Rottjakob, MPH', 'role': 'CONTACT', 'email': 'rottjakob@xund.ai'}], 'overallOfficials': [{'name': 'Lars-Peter Kamolz, Univ. Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medizinische Universität Graz, Universitätsklinik für Chirurgie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'XUND Solutions GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medical University of Graz', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}