Referral of Patients to Hepatology With Hepatoscope

NCT06387745 | Not Yet Recruiting FDA Device

• 1 other identifier: US-REFERRAL
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients identified as being at risk of liver fibrosis because of a positive Fibrosis-4 (FIB-4) test in the primary care setting will be offered be enrolled in the trial and to undergo an Hepatoscope exam (external non-invasive ultrasound imaging exam) to screen for liver fibrosis (with stiffness measurements) and/or steatosis (with ultrasound parameters related to fatty liver). All patients presenting with a liver stiffness value of at least 6.5 kilopascal (kPa) will be referred to the tertiary hepatology consultations for further assessment. Hepatoscope measurements will be compared to the standard of care for these patients, as defined at the tertiary hepatology center.

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

• Positive Predictive Value for significant fibrosis

  Estimation of Positive Predictive Value in percentage with 95% confidence interval for estimation of significant fibrosis.

  at study completion: 12 months

Secondary Outcomes (3)

• Correlation of stiffness measurements

  at study completion: 12 months

• Concordance of stiffness measurements

  at study completion: 12 months

• Diagnostic performance of liver stiffness measurements

  at study completion: 12 months

Study Arms (1)

Investigational Arm

EXPERIMENTAL

Single arm study protocol

Device: Hepatoscope

Interventions

Hepatoscope DEVICE

The Hepatoscope is a non-invasive external ultrasound imaging device, intended for general purpose pulse echo ultrasound imaging, and soft tissue elasticity imaging of the human body. In addition, the Hepatoscope provides measurements of shear wave speed and tissue stiffness, ultrasound beam attenuation and estimates of speed of sound, in internal structures of the body.

Investigational Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with any of the following
• Elevated liver enzymes (AST, ALT, Gamma-GT, AP)
• Type 2 diabetes
• Elements of metabolic syndrome
• Patients who consent in written to participate in the Clinical Investigation after being orally informed on the objectives and methods of the Clinical Investigation

You may not qualify if:

• Patients with active implants such as pacemakers, defibrillators, pumps, etc.
• Patients presenting wounds at the location where the Hepatoscope probe shall be placed on patients' skin,
• Pregnant and breastfeeding women,
• People deprived of their freedom rights.

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• E-Scopics: collaborator

Study Officials

• Luisa Vonghia, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luisa Vonghia, MD, PhD

CONTACT

038213659; luisa.vonghia@uza.be

Sven Francque, MD, PhD

CONTACT

038214572; sven.francque@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 29, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share