Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-01 @ 3:29 PM
Study NCT ID:
NCT04782050
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2021-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation
Sponsor:
E-Scopics
Organization:
Study Overview
Official Title:
Diagnostic échographique Non-invasif Des Maladies Chroniques du Foie en Consultation d'hépatologie
Status:
COMPLETED
Status Verified Date:
2023-04
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:
DIACEPA
Brief Summary:
Early screening and monitoring of chronic liver diseases in hepatology practice has become crucial. To achieve this goal, hepatology clinics need simple and available tools at the point-of-care to perform disease severity assessment. The objective of this study is to assess the performance of a new non-invasive ultrasound-based system for the assessment of liver fibrosis and steatosis severity, via ultrasound biomarkers such as tissue stiffness (correlated to fibrosis severity) and ultrasound tissue attenuation (correlated to steatosis extent).
Detailed Description:
The study will enroll adult patients with known chronic liver disease, and referred to a hepatology outpatient visit for liver fibrosis assessment.
Performances will be assessed from correlation coefficients between biomarkers estimated by the medical device subject of the research and reference measurements obtained non-invasively from other commercially available equipment.
Repeatability and reproducibility of biomarkers estimations by the medical device subject of the research will be assessed from intraclass correlation coefficients.
Performances will be assessed from correlation coefficients between biomarkers estimated by the medical device subject of the research and reference measurements obtained non-invasively from other commercially available equipment.
Repeatability and reproducibility of biomarkers estimations by the medical device subject of the research will be assessed from intraclass correlation coefficients.
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?:
False
Is an FDA AA801 Violation?: