Velacur by Sonic Incytes for Portal Hypertension

Last updated: August 13, 2023
Sponsor: Indiana University
Overall Status: Completed

Phase

N/A

Condition

Stress

Vascular Diseases

Liver Disorders

Treatment

Velacur

Clinical Study ID

NCT04576897
LI for Portal Hypertenstion
2009698702
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Velacur
Phase:
Study Start date:
February 01, 2021
Estimated Completion Date:
April 19, 2022

Study Description

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.

Connect with a study center

  • Indiana University Division of Gastroenterolgy and Hepatology

    Indianapolis, Indiana 46202
    United States

    Site Not Available

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