Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00612-39 | Other Identifier | ANSM (France - n°IDRCB) | |
| 21.01563.000015 | Other Identifier | Ethical committee CPP Est I |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital, Bordeaux | OTHER |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound liver assessment | Device | The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At study completion, 1 year |
| 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. | At study completion, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Repeatability intraclass correlation coefficients (ICC) | Repeatability will be assessed by calculating the ICC across 2 series of measurements performed by the same operator. | At study completion, 1 year |
| Reproducibility intraclass correlation coefficients (ICC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Victor de Lédinghen, MD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux University Hospital | Pessac | 33600 | France |
Not provided
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D054459 | Elasticity Imaging Techniques |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
All patients recruited will receive routine care for liver assessment followed by an exam using the device subject of the research.
Not provided
Not provided
Not provided
Not provided
|
Reproducibility will be assessed by calculating the ICC across 2 series of measurements performed by 2 different operators. |
| At study completion, 1 year |
| D005234 | Fatty Liver |