Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392464
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-26
Brief Title:
Validation of Naevia Medical in Valvulopathies
Sponsor:
Dilemma Solutions SL
Organization:
Dilemma Solutions SL
Study Overview
Official Title:
Clinical Validation Study of Naevia Medical a Clinical Decision Support System in Heart Valve Disease
Status:
RECRUITING
Status Verified Date:
2024-04
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:
CDSS-Valve
Brief Summary:
The study aims to validate naevia medical a knowledge-based clinical decision support system CDSS for clinical benefit and safety in cases of cardiac valvulopathies Using a series of retrospective clinical cases of heart valve disease the research will evaluate the number of appropriate and inappropriate recommendations during baseline measurement conventional management and after CDSS activation
Detailed Description:
The objective of this study is to validate both the clinical benefit and safety of a knowledge-based clinical decision support system CDSS naevia medical applied to clinical cases of cardiac valvulopathies
naevia medical aims to bridge the gap between scientific evidence and medical practice by improving adherence to scientific recommendations
The research aims to establish and verify that the naevia medical product is suitable for its intended purposes and provides the specified intended functionality as outlined by its manufacturer under normal conditions of use It seeks to verify the clinical benefits of the product compared to conventional management by enhancing healthcare professionals ability to provide a greater number of scientifically based recommendations tailored to each patients specific situation Additionally the study aims to establish the clinical safety of the product by identifying potential undesirable side effects under normal usage conditions and evaluating whether these effects constitute acceptable risks in relation to the benefits provided
To achieve these objectives a clinical research study will be conducted to assess naevia medicals capacity to increase appropriate recommendations and decrease inappropriate recommendations received by patients with valvulopathy compared to conventional management without support
The study proposes a pre-test-post-test design with a randomly assigned group utilizing a longitudinal approach with repeated measures and retrospective validation Evaluation criteria will focus on the number of appropriate and inappropriate recommendations during baseline measurement conventional management and after CDSS activation using a series of retrospective clinical cases of heart valve disease
naevia medical aims to bridge the gap between scientific evidence and medical practice by improving adherence to scientific recommendations
The research aims to establish and verify that the naevia medical product is suitable for its intended purposes and provides the specified intended functionality as outlined by its manufacturer under normal conditions of use It seeks to verify the clinical benefits of the product compared to conventional management by enhancing healthcare professionals ability to provide a greater number of scientifically based recommendations tailored to each patients specific situation Additionally the study aims to establish the clinical safety of the product by identifying potential undesirable side effects under normal usage conditions and evaluating whether these effects constitute acceptable risks in relation to the benefits provided
To achieve these objectives a clinical research study will be conducted to assess naevia medicals capacity to increase appropriate recommendations and decrease inappropriate recommendations received by patients with valvulopathy compared to conventional management without support
The study proposes a pre-test-post-test design with a randomly assigned group utilizing a longitudinal approach with repeated measures and retrospective validation Evaluation criteria will focus on the number of appropriate and inappropriate recommendations during baseline measurement conventional management and after CDSS activation using a series of retrospective clinical cases of heart valve disease
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None