Velacur by Sonic Incytes for Portal Hypertension

NCT04576897 | Completed Results FDA Device

• 2 other identifiers: LI for Portal Hypertenstion2009698702
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Hypertension; Chronic Advanced Liver Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Other Outcomes (1)

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

  one day

Study Arms (1)

Velacur by Sonic Incytes

EXPERIMENTAL

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

Diagnostic Test: Velacur

Interventions

Velacur DIAGNOSTIC_TEST

Ultrasound elasticity imaging

Velacur by Sonic Incytes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Sonic Incytes: collaborator

Study Sites (1)

Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Samer Gawrieh
• Organization: Indiana University

sgawrieh@iu.edu

317-278-9326

Study Officials

• Samer Gawrieh, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open label study in that all participants will receive the same study procedures. Participants only receive this Velacur intervention if they are enrolled in this trial.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Model Details: All participants will undergo quantitative ultrasound with Velacur by Sonic Incytes by a certified technician.

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 6, 2020
• Study Start: February 1, 2021
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2022
• Last Updated: September 5, 2023
• Results First Posted: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)