- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06933550
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
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)
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).
The main question it aims to answer is:
- Can a detailed medical history with additional enriched information from XUND improve the quality of outpatient care?
Selected patients in the waiting area of the emergency department will record their symptoms on a tablet and answer the questions asked about their symptoms.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lukas Seper
- Phone Number: 0043 1 9053804 222
- Email: seper@xund.ai
Study Contact Backup
- Name: Pia Rottjakob, MPH
- Email: rottjakob@xund.ai
Study Locations
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-
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Graz, Austria
- Recruiting
- Medical University of Graz
-
Contact:
- Lars-Peter Kamolz, Univ.-Prof. Dr.med., MSc
- Phone Number: +43 316 385-14685
- Email: lars.kamolz@medunigraz.at
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Principal Investigator:
- Lars-Peter Kamolz, Univ.-Prof. Dr.med., MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- a signed informed consent form;
- signed consent and admission to the emergency department of the emergency medicine clinic
- Triage category 3, 4 or 5 based on the triage procedure according to the Manchester triage system used in Austria
- the physical and mental ability to operate the tablet and answer the questions
- 18 years of age or older;
- knowledge of the German language.
Exclusion Criteria:
- not meeting all inclusion criteria
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
XUND Symptom Checker
Time Frame: through investigation completion, an average of 1 year
|
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.
|
through investigation completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lars-Peter Kamolz, Univ. Prof. Dr., Medizinische Universität Graz, Universitätsklinik für Chirurgie
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 892459
- 102478757 (Other Identifier: BASG/AGES Institute Surveillance)
Drug and device information, study documents
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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