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

NCT05908006 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-06-18

No results posted yet for this study

Summary

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).

Conditions

  • Non-alcoholic Fatty Liver Disease (NAFLD)

Interventions

DEVICE

Velacur

Imaging Procedures Comparison

Sponsors & Collaborators

  • Sonic Incytes

    collaborator INDUSTRY

  • GI Alliance

    lead OTHER

Principal Investigators

  • Sri Naveen Surapaneni, MD · GI Alliance

  • Reed B Hogan, III, MD · GI Alliance

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-15
Primary Completion
2023-12-30
Completion
2024-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05908006 on ClinicalTrials.gov