Liver DiseasesDIACEPANCT04782050
Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation
A study testing Ultrasound liver assessment in people with Liver Diseases and Liver Cirrhosis, run by E-Scopics at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Diseases, Liver Cirrhosis, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Ultrasound liver assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2021to 29 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic échographique Non-invasif Des Maladies Chroniques du Foie en Consultation d'hépatologie
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).
Read the 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.
- Being tested
- Ultrasound liver assessment
- Keywords
- Elastography, Attenuation, Sound speed, Ultrasound
- Medical subject headings
- Liver Diseases, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound liver assessmentDevice
Also called Elastography, Ultrasound attenuation, Sound speed
The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Not described Receives: Device: Ultrasound liver assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At study completion, 1 year
Secondary outcomes (2)
Repeatability intraclass correlation coefficients (ICC)
Repeatability will be assessed by calculating the ICC across 2 series of measurements performed by the same operator.
Measured: At study completion, 1 year
Reproducibility intraclass correlation coefficients (ICC)
Reproducibility will be assessed by calculating the ICC across 2 series of measurements performed by 2 different operators.
Measured: At study completion, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start15 Sep 2021
- Primary completion29 Aug 2022
- Study completion29 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- E-Scopics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Bordeaux
- Responsible party
- Sponsor
- Investigators
- Victor de Lédinghen, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782050
- Sponsor's protocol ID
- ES201
- Other IDs
- 2021-A00612-39, 21.01563.000015
- Acronym
- DIACEPA
- Status last verified
- Apr 2023
- First submitted
- 1 Mar 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic échographique Non-invasif Des Maladies Chroniques du Foie en Consultation d'hépatologie
- ClinicalTrials.gov ID
- NCT04782050
- Acronym / sponsor ID
- DIACEPA / ES201
- Keywords
- Elastography, Attenuation, Sound speed, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- E-ScopicsIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Bordeaux
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients recruited will receive routine care for liver assessment followed by an exam using the device subject of the research.
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Device: Ultrasound liver assessment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound liver assessmentAlso: Elastography, Ultrasound attenuation, Sound speedThe intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research. | Device | Study arm |
Primary outcome
Correlation of biomarkers to existing biomarker references
Time frame: At study completion, 1 year
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
Time frame: At study completion, 1 year
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.
2 secondary outcomes
Repeatability intraclass correlation coefficients (ICC)
Time frame: At study completion, 1 year
Reproducibility intraclass correlation coefficients (ICC)
Time frame: At study completion, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor de Lédinghen, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound liver assessment in people with Liver Diseases and Liver Cirrhosis, run by E-Scopics at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of biomarkers to existing biomarker references (time frame: At study completion, 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.