Velacur by Sonic Incytes for Portal Hypertension

Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04576897
• Other study ID #: LI for Portal Hypertenstion
• Secondary ID: 2009698702
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: April 19, 2022

Study information

• Verified date: August 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 19, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Advanced Liver Disease
• Hypertension
• Hypertension, Portal
• Liver Diseases
• Portal Hypertension

Intervention

Diagnostic Test:
• Velacur
Ultrasound elasticity imaging

Locations

Country	Name	City	State
United States	Indiana University Division of Gastroenterolgy and Hepatology	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Sonic Incytes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation of Velacur Measurements to Non-Invasive Blood Markers for Predicting Advanced Fibrosis	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.	one day
Primary	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.	one day
Primary	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	one day