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OpenTrials
Enrolling by Invitation

NCT Number: NCT06953830

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

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.

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Key information

Conditions

Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WJB Dorn VA Medical Center 6439 Garners Ferry Road Columbia, South Carolina 29209

Columbia, South Carolina, 29209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibration-controlled transient elastography

Device

Liver and spleen stiffness measurements using vibration-controlled transient elastography

Primary outcomes

  1. Spleen Stiffness measurement

    Time frame: 1 year

    Percent of participants with valid spleen stiffness measurements using vibration controlled transient elastography

Sponsors and collaborators

Lead sponsor

William Jennings Bryan Dorn VA Medical Center

Fed

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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