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Enrolling by invitation NCT06953830

Optimal Measurement of Spleen Stiffness Among Veterans With Metabolic Dysfunction-Associated Steatotic Liver Disease

No phase Interventional Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vibration-controlled transient elastography.
Who it may be relevant to
Registry conditions: Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

A growing number of people are being diagnosed with fatty liver disease, also known as metabolic-dysfunction associated liver disease (MASLD). Fatty liver disease can unknowingly progress to serious liver disease and even permanent scarring (cirrhosis).The purpose of this research is to learn the best way to detect serious liver disease as early as possible in patients with fatty liver disease by measuring the stiffness of the spleen. Secondarily, the study hopes to understand how the stiffness of the spleen relates to the severity of liver disease.

Interventions

  • Device Vibration-controlled transient elastography
    Liver and spleen stiffness measurements using vibration-controlled transient elastography

Primary outcome measures

  • Spleen Stiffness measurement [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Able to consent for participation in a clinical study
  • Able to read and comprehend English
  • Evidence of fatty liver disease on previous liver biopsy, imaging or clinical documentation

Exclusion criteria

  • Pregnant
  • Known decompensated cirrhosis or hepatocellular carcinoma
  • Absence of spleen
  • Documentation of alcohol use disorder or alcohol use greater than 20g/day for women or greater than 30 g/day for men
  • Unable to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • WJB Dorn VA Medical Center 6439 Garners Ferry Road Columbia, South Carolina 29209 — Columbia

Identifiers

NCT: NCT06953830 · 1766537-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗