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Clinical Performance of LIVERFASt Test Compared w/ Liver Biopsy in Patients w/ NAFLD.

NCT04579874 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2022-08-02

No results posted yet for this study

Summary

The primary objective of this study is to assess the clinical performance of LIVERFAStTM In Vitro Diagnostic (IVD) Tests (Fibrosis score, Activity score and Steatosis score) in NAFLD suspected patients for staging of fibrosis and for grading of inflammatory activity and steatosis, taking as reference the liver biopsy with histological classification of the elementary lesions determined according to SAF scores (Bedossa P., Hepatology 2012).

The secondary objective is to assess the performance of LIVERFAStTM for the histological definition of NAFLD, including NAFL and NASH and severe NASH

Conditions

  • Non-Alcoholic Fatty Liver Disease
  • Non-Alcoholic Steatohepatitis
  • Liver Fibroses
  • Liver Inflammation
  • Liver Steatoses

Interventions

DIAGNOSTIC_TEST

LIVERFASt

blood draw

Sponsors & Collaborators

  • Fibronostics USA, Inc

    lead OTHER

Principal Investigators

  • Ronald Quiambao, MD · Fibronostics USA, Inc

  • Imtiaz Alam, MD · Ohio Gastroenterology and Liver Institute

  • Sven Henrichwark · Fibronostics USA, Inc

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-01-07
Primary Completion
2021-12-15
Completion
2022-04-15
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 NCT04579874 on ClinicalTrials.gov