Velacur by Sonic Incytes for Portal Hypertension

NCT ID: NCT04576897

Last Updated: 2023-09-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-04-19

Brief Summary

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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

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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.

Conditions

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Portal Hypertension Chronic Advanced Liver Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will undergo quantitative ultrasound with Velacur by Sonic Incytes by a certified technician.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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Velacur by Sonic Incytes

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

Group Type EXPERIMENTAL

Velacur

Intervention Type DIAGNOSTIC_TEST

Ultrasound elasticity imaging

Interventions

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Velacur

Ultrasound elasticity imaging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sonic Incytes

INDUSTRY

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Samer Gawrieh

Professor of Clinical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samer Gawrieh, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Indiana University Division of Gastroenterolgy and Hepatology

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2009698702

Identifier Type: OTHER

Identifier Source: secondary_id

LI for Portal Hypertenstion

Identifier Type: -

Identifier Source: org_study_id

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