Referral of Patients to Hepatology With Hepatoscope
ConditionChronic Liver Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Antwerp
About this trial
Patients identified as being at risk of liver fibrosis because of a positive Fibrosis-4 (FIB-4) test in the primary care setting will be offered be enrolled in the trial and to undergo an Hepatoscope exam (external non-invasive ultrasound imaging exam) to screen for liver fibrosis (with stiffness measurements) and/or steatosis (with ultrasound parameters related to fatty liver). All patients presenting with a liver stiffness value of at least 6.5 kilopascal (kPa) will be referred to the tertiary hepatology consultations for further assessment. Hepatoscope measurements will be compared to the standard of care for these patients, as defined at the tertiary hepatology center.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with any of the following
Elevated liver enzymes (AST, ALT, Gamma-GT, AP)
Type 2 diabetes
Elements of metabolic syndrome
Disqualifiers
Patients with active implants such as pacemakers, defibrillators, pumps, etc.
Patients presenting wounds at the location where the Hepatoscope probe shall be placed on patients' skin,
Pregnant and breastfeeding women,
People deprived of their freedom rights.
Trial design
Design model
Single group
Treatments tested in this trial
Hepatoscope
DeviceThe Hepatoscope is a non-invasive external ultrasound imaging device, intended for general purpose pulse echo ultrasound imaging, and soft tissue elasticity imaging of the human body. In addition, the Hepatoscope provides measurements of shear wave speed and tissue stiffness, ultrasound beam attenuation and estimates of speed of sound, in internal structures of the body.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Investigational ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Positive Predictive Value for significant fibrosis
Estimation of Positive Predictive Value in percentage with 95% confidence interval for estimation of significant fibrosis.
Time frame
at study completion: 12 monthsSecondary outcomes
1
Correlation of stiffness measurements
Liver stiffness measurements performed with the device subject of the research and competitor device will be compared by analysis of correlation. The analysis outcome will be the R² coefficient and its p value.
Time frame
at study completion: 12 months2
Concordance of stiffness measurements
Liver stiffness measurements performed with the device subject of the research and competitor device will be compared by analysis of concordance. The analysis outcome will be the Concordance Correlation Coefficients (CCC) and 95% confidence intervals.
Time frame
at study completion: 12 months3
Diagnostic performance of liver stiffness measurements
Area under the receiver operating characteristic (ROC) curve will be used an a general assessment of diagnostic performance against dichotomized population according to referral outcome. Diagnostic estimators in the studied population will be derived from the ROC analysis: sensitivity, specificity, positive and negative predictive values.
Time frame
at study completion: 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Antwerp
Lead sponsor
E-Scopics
Collaborator
Source ClinicalTrials.gov