Velacur by Sonic Incytes for Portal Hypertension

Indiana University70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Portal Hypertension Chronic Advanced Liver Disease

Interventions

VelacurDIAGNOSTIC_TEST

Ultrasound elasticity imaging

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adults aged 18 years or older 2. Ability to provide informed consent 3. Planned standard of care upper endoscopy to screen for varices 4. Planned standard of care transjugular liver biopsy with portal pressure measurement Exclusion Criteria: 1. Inability or refusal to provide informed consent 2. Fasting for less than three hours prior to the scan 3. Subject is a pregnant or lactating female 4. Subject with current, significant alcohol consumption 5. Patients with a pacemaker or defibrillator 6. Acute hepatitis defined as AST/ALT \> 500 U/L 7. Ascites 8. post liver transplantation

Locations (1)

Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: one day

Data from ClinicalTrials.gov

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