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Velacur by Sonic Incytes for Portal Hypertension

Primary Purpose

Portal Hypertension, Chronic Advanced Liver Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Velacur
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Portal Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults aged 21 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

Sites / Locations

  • Indiana University Division of Gastroenterolgy and Hepatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Velacur by Sonic Incytes

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
September 30, 2020
Last Updated
August 13, 2023
Sponsor
Indiana University
Collaborators
Sonic Incytes
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1. Study Identification

Unique Protocol Identification Number
NCT04576897
Brief Title
Velacur by Sonic Incytes for Portal Hypertension
Official Title
Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Liver Stiffness Measurement Using Liver Incytes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 19, 2022 (Actual)
Study Completion Date
April 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Sonic Incytes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension, Chronic Advanced Liver Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will undergo quantitative ultrasound with Velacur by Sonic Incytes by a certified technician.
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Velacur by Sonic Incytes
Arm Type
Experimental
Arm Description
Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Velacur.
Intervention Type
Diagnostic Test
Intervention Name(s)
Velacur
Intervention Description
Ultrasound elasticity imaging
Primary Outcome Measure Information:
Title
Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD)
Description
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.
Time Frame
one day
Title
Platelet Count for Participants With Compensated Advanced Chronic Liver Disease
Description
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
Time Frame
one day
Other Pre-specified Outcome Measures:
Title
Correlation of Velacur Measurements to Non-Invasive Blood Markers for Predicting Advanced Fibrosis
Description
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.
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samer Gawrieh, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Division of Gastroenterolgy and Hepatology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Velacur by Sonic Incytes for Portal Hypertension

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