Velacur by Sonic Incytes for Portal Hypertension

Indiana University

Status: Completed

Conditions: Portal Hypertension; Chronic Advanced Liver Disease

Treatments: Diagnostic Test: Velacur

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04576897

LI for Portal Hypertenstion

2009698702 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Velacur by Sonic Incytes

Experimental group

Description:

Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Velacur.

Treatment:

Diagnostic Test: Velacur