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:
XUND Solutions GmbH
Organization:
Study Overview
Official Title:
FFG PREMEDICAL (Clinical Investigation of a Medical Device According to MDR Article 82, Para.1 and Austrian Law ยง13 Para. 3 MPG, BGBI. I No. 122/2021 - Study Without Influence on Diagnostics/Therapy)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 102478757 | OTHER | BASG/AGES Institute Surveillance | View |