Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT07123818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AI for Detection of Brain Aneurysm: Low-cost Opportunistic Screening
Sponsor:
Ziekenhuis Oost-Limburg
Organization:
Study Overview
Official Title:
AI for Detection of Brain Aneurysm: Low-cost Opportunistic Screening
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
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:
AIDALOS-III
Brief Summary:
The goal of this clinical trial is to verify the opportunistic screening potential of the AI software for detection of brain UIA on routinely performed brain NECT scans in a prospective setting in the Belgian population.
The main question the study aims to answer is: Does the AI algorithm has potential to be used as clinical screening potential for detection of brain anerysms on brain NECT scans?
The performance and the clinical use of the AI algorithm will be measured based on the number of aneurysms detected by the software compared to the number of aneurysms confirmed by review of a radiologist compared to the number of aneurysms already known by review of the electronic patient file.
Participants will be followed-up following Standard-of-Care (SoC). In addition, participants will be requested to complete a questionnaire (the EQ-5D-5L questionnaire).
The main question the study aims to answer is: Does the AI algorithm has potential to be used as clinical screening potential for detection of brain anerysms on brain NECT scans?
The performance and the clinical use of the AI algorithm will be measured based on the number of aneurysms detected by the software compared to the number of aneurysms confirmed by review of a radiologist compared to the number of aneurysms already known by review of the electronic patient file.
Participants will be followed-up following Standard-of-Care (SoC). In addition, participants will be requested to complete a questionnaire (the EQ-5D-5L questionnaire).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: