Velacur by Sonic Incytes for Portal Hypertension

Study Overview
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Brief Summary
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This is a cross sectional study that evaluates the relationship between LSM (liver stiffness measurement) by Liver Incytes in patients with cACLD (compensated advanced chronic liver disease) and manifestations of portal hypertension.

Detailed Description
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The purpose of this study is to assess the severity of portal hypertension in people with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplant by measuring liver stiffness with the Liver Incytes device (Velacur) and comparing the performance of LSM (liver stiffness measurement) via Velcaur and transient elastography via FibroScan to esophageal varices.

Official Title
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Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Liver Stiffness Measurement Using Liver Incytes

Conditions
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Portal Hypertension, Chronic Advanced Liver Disease

Intervention / Treatment
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* Diagnostic Test: Velacur


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18 years or older Ability to provide informed consent Planned standard of care upper endoscopy to screen for varices Planned standard of care transjugular liver biopsy with portal pressure measurement Exclusion Criteria: Inability or refusal to provide informed consent Fasting for less than three hours prior to the scan Subject is a pregnant or lactating female Subject with current, significant alcohol consumption Patients with a pacemaker or defibrillator Acute hepatitis defined as AST/ALT > 500 U/L Ascites post liver transplantation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will undergo quantitative ultrasound with Velacur by Sonic Incytes by a certified technician.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Velacur by Sonic Incytes<br>Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Velacur. | Diagnostic Test: Velacur<br>* Ultrasound elasticity imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD) | Comparing the performance of Velacur by Sonic Incytes to transient elastography via FibroScan® in the same patient population to determine if either test is more accurate in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices. | one day | 
| Platelet Count for Participants With Compensated Advanced Chronic Liver Disease | Comparing the platelet count in the same patient population to determine Velacur's accuracy in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices | one day |