CompletedNot Applicable

Velacur by Sonic Incytes for Portal Hypertension

United States70 participantsStarted 2021-02-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD)

Timeframe: one day

Platelet Count for Participants With Compensated Advanced Chronic Liver Disease

Timeframe: one day

Trial details

NCT IDNCT04576897

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-19

Results submitted2023-02-01

View on ClinicalTrials.gov More Portal Hypertension trials