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Not listed No phase listed Observational

Validation Study of the Velacur System in Comparison to MRE & MRI-PDFF in Patients With (Suspected) Liver Disease

ClinicalTrials.gov ID: NCT05908006

Public ClinicalTrials.gov record NCT05908006. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 10:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Comparison of Steatosis and Fibrosis Measurements From Velacur and MRE/MRI-PDFF in Patients With Chronic Liver Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this open-label, non-randomized, prospective study is to compare Velacur and MRE in all sexes, 18-80 years old with Non-Alcoholic Fatty Liver Disease (NAFLD). The main aims is to: * Validate the use of Velacur and elastography cut offs in a patient cohort with all types of chronic liver disease, against MRE results for fibrosis staging. * Validate the use of Velacur and attenuation cut offs in a patient cohort with all types of chronic liver disease, against MRI-PDFF results for steatosis staging. Participants will Study participants will attend 1 study visit, in which measurement of liver stiffness with Velacur and FibroScan, will be performed by a certified technician. As part of Visit 1, Patients will also complete an MRI exam which will include both MRE and MRI-PDFF measurements (MRI imaging can take place within 28 days of the Velacur scan).

Study identification

NCT ID
NCT05908006
Recruitment status
Not listed
Study type
Observational
Phase
Not listed
Lead sponsor
GI Alliance
Other
Enrollment
100 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 14, 2023
Primary completion
Dec 29, 2023
Completion
Jan 30, 2024
Last update posted
Jun 17, 2023

2023 – 2024

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
GI Alliance-Flowood, MS Flowood Mississippi 39232
GI Alliance-Webster, TX Webster Texas 77598

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05908006, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 17, 2023 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05908006 live on ClinicalTrials.gov.

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