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Completed

NCT Number: NCT04576897

Velacur by Sonic Incytes for Portal Hypertension

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.

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Key information

Conditions

Portal Hypertension Chronic Advanced Liver Disease Digestive System Diseases Hypertension, Portal Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Velacur

Diagnostic Test

Ultrasound elasticity imaging

Primary outcomes

  1. Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD)

    Time frame: one day

    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.

  2. Platelet Count for Participants With Compensated Advanced Chronic Liver Disease

    Time frame: one day

    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

Other outcomes

  1. Correlation of Velacur Measurements to Non-Invasive Blood Markers for Predicting Advanced Fibrosis

    Time frame: one day

    This was initially included in our study protocol as an outcome measurement. However, we realized that these markers were not being routinely collected and the data are simply not available. Therefore, no outcome data are or can be included for this measurement.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Sonic Incytes

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2020
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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