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New ultrasound device could spot liver disease early and speed up specialist care

NCT ID NCT06387745

Diagnosis Sponsor: University Hospital, Antwerp Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new, non-invasive ultrasound device called the Hepatoscope to screen for liver scarring (fibrosis) and fatty liver in people at risk. Researchers will enroll 200 patients with risk factors like diabetes or elevated liver enzymes. Those with high stiffness readings on the scan will be referred to a liver specialist, and the device's accuracy will be compared to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hepatoscope (non-invasive ultrasound device)
What this could lead to
If successful, this could provide a simple, non-invasive way to identify patients who need specialist care for chronic liver disease, potentially catching problems earlier.
What could go wrong
This is an early-stage diagnostic study with 200 participants, so results may not apply to everyone. The device's accuracy compared to standard tests is still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

fibrotic liver disease liver disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic liver disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Universitair Ziekenhuis Antwerpen

    RECRUITING

    Edegem, Antwerp, 2650, Belgium

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