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

NCT06953830 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 1766537-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)

Outcome Measures

Primary Outcomes (1)

• Spleen Stiffness measurement

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

  1 year

Study Arms (1)

Spleen Stiffness Measurements

EXPERIMENTAL

Participants with metabolic-dysfunction associated steatotic liver disease will undergo liver and spleen stiffness measurements using vibration-controlled transient elastography

Device: Vibration-controlled transient elastography

Interventions

Vibration-controlled transient elastography DEVICE

Liver and spleen stiffness measurements using vibration-controlled transient elastography

Spleen Stiffness Measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• William Jennings Bryan Dorn VA Medical Center: lead

Study Sites (1)

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

Columbia, South Carolina, 29209, United States

Location

Study Officials

• Nicholas Hoppmann, MD

  Columbia VA Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 1, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)