search
Back to results

Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation (DIACEPA)

Primary Purpose

Liver Diseases, Liver Cirrhosis, Non-Alcoholic Fatty Liver Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound liver assessment
Sponsored by
E-Scopics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Diseases focused on measuring Elastography, Attenuation, Sound speed, Ultrasound

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with known chronic liver disease and referred to the outpatient hepatology clinic for a consultation focused on chronic liver disease severity assessment, independently of the study (=in routine patient care).
  • Patient who voluntarily consents to participate in the study, after being informed on study objectives and personal rights
  • Patient who is registered to the French social security program

Exclusion Criteria:

  • Adult patients under guardianship
  • Adult patients not being under guardianship, unable to express consent for participation
  • Pregnant women
  • Breastfeeding women
  • Patients under deprivation of liberty
  • In-hospital patients not having given their consent to participate, or admitted in emergency
  • Patients admitted in social and care centers for other reasons than those of the research
  • Patients enrolled in other studies that have the potential to interfere with current research, or during the exclusion period forced by their participation in other research.

Sites / Locations

  • Bordeaux University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study arm

Arm Description

Outcomes

Primary Outcome Measures

Correlation of biomarkers to existing biomarker references
Biomarkers measurements performed with the device subject of the research and commercially available equipment (2 other devices used in routine care) will be compared by analysis of correlation. The analysis outcome will be the R² coefficient and its p value.
Diagnostic performance of biomarkers in research
Area under the receiver operating characteristic (ROC) curve will be used an a general assessment of diagnostic performance against dichotomized population according to commercially available diagnostic biomarkers. Conventional diagnostic estimators in the studied population will be derived from the ROC analysis: sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy.

Secondary Outcome Measures

Repeatability intraclass correlation coefficients (ICC)
Repeatability will be assessed by calculating the ICC across 2 series of measurements performed by the same operator.
Reproducibility intraclass correlation coefficients (ICC)
Reproducibility will be assessed by calculating the ICC across 2 series of measurements performed by 2 different operators.

Full Information

First Posted
March 1, 2021
Last Updated
April 24, 2023
Sponsor
E-Scopics
Collaborators
University Hospital, Bordeaux
search

1. Study Identification

Unique Protocol Identification Number
NCT04782050
Brief Title
Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation
Acronym
DIACEPA
Official Title
Diagnostic échographique Non-invasif Des Maladies Chroniques du Foie en Consultation d'hépatologie
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
August 29, 2022 (Actual)
Study Completion Date
August 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
E-Scopics
Collaborators
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases, Liver Cirrhosis, Non-Alcoholic Fatty Liver Disease
Keywords
Elastography, Attenuation, Sound speed, Ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients recruited will receive routine care for liver assessment followed by an exam using the device subject of the research.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ultrasound liver assessment
Other Intervention Name(s)
Elastography, Ultrasound attenuation, Sound speed
Intervention Description
The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.
Primary Outcome Measure Information:
Title
Correlation of biomarkers to existing biomarker references
Description
Biomarkers measurements performed with the device subject of the research and commercially available equipment (2 other devices used in routine care) will be compared by analysis of correlation. The analysis outcome will be the R² coefficient and its p value.
Time Frame
At study completion, 1 year
Title
Diagnostic performance of biomarkers in research
Description
Area under the receiver operating characteristic (ROC) curve will be used an a general assessment of diagnostic performance against dichotomized population according to commercially available diagnostic biomarkers. Conventional diagnostic estimators in the studied population will be derived from the ROC analysis: sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy.
Time Frame
At study completion, 1 year
Secondary Outcome Measure Information:
Title
Repeatability intraclass correlation coefficients (ICC)
Description
Repeatability will be assessed by calculating the ICC across 2 series of measurements performed by the same operator.
Time Frame
At study completion, 1 year
Title
Reproducibility intraclass correlation coefficients (ICC)
Description
Reproducibility will be assessed by calculating the ICC across 2 series of measurements performed by 2 different operators.
Time Frame
At study completion, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with known chronic liver disease and referred to the outpatient hepatology clinic for a consultation focused on chronic liver disease severity assessment, independently of the study (=in routine patient care). Patient who voluntarily consents to participate in the study, after being informed on study objectives and personal rights Patient who is registered to the French social security program Exclusion Criteria: Adult patients under guardianship Adult patients not being under guardianship, unable to express consent for participation Pregnant women Breastfeeding women Patients under deprivation of liberty In-hospital patients not having given their consent to participate, or admitted in emergency Patients admitted in social and care centers for other reasons than those of the research Patients enrolled in other studies that have the potential to interfere with current research, or during the exclusion period forced by their participation in other research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor de Lédinghen, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bordeaux University Hospital
City
Pessac
ZIP/Postal Code
33600
Country
France

12. IPD Sharing Statement

Learn more about this trial

Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation

We'll reach out to this number within 24 hrs