Velacur by Sonic Incytes for Portal Hypertension

Not Applicable

Completed

• Conditions: Portal Hypertension; Chronic Advanced Liver Disease
• Interventions: Diagnostic Test: Velacur

• Registration Number: NCT04576897
• Lead Sponsor: Indiana University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-06
• Study Start: 2021-02-01
• Primary Completion: 2022-04-19
• Study Completion: 2022-04-19
• Results First Submitted: 2023-02-01
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-13
• Last Update Submitted: 2023-08-13
• Results First Posted: 2023-09-05
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Velacur by Sonic Incytes	Velacur	Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Velacur.

Primary Outcome Measures

Name	Time	Method
Platelet Count for Participants With Compensated Advanced Chronic Liver Disease	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
Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD)	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.

Trial Locations

Locations (1)

Indiana University Division of Gastroenterolgy and Hepatology; 🇺🇸 Indianapolis, Indiana, United States