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Can a new ultrasound device spot liver damage without a biopsy?

NCT ID NCT03957070

Diagnosis Sponsor: Sonic Incytes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing the Liver Incyte system, an ultrasound device that measures how stiff the liver is, to see if it can tell healthy people apart from those with liver fibrosis or steatosis. The trial includes 140 adults, some healthy and some with a history of hepatitis C or non-alcoholic steatohepatitis. Each participant receives a Liver Incyte scan and a FibroScan on the same day, and researchers compare how well the two devices distinguish healthy livers from damaged ones.

What this could mean

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

Active substance
Liver Incyte ultrasound elasticity imaging device
What this could lead to
If it works, this could offer a simpler, non-invasive way to detect liver scarring and fat buildup, possibly without the need for a separate FibroScan machine.
What could go wrong
This is an early feasibility study with 140 people, so it may not show clear enough accuracy to replace existing tools. Ultrasound measurements can vary with body type and operator technique.

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

140 people

The number who actually took part.

Started

Feb 2019

Finished

Apr 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

19 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Any sex, ages 19-75 years inclusively * Individuals with a history of chronic Hepatitis C (HCV) or non-alcoholic steatohepatitis (NASH). Patients with history of Hepatitis C must have completed treatment and achieved Sustained viral response at 12 weeks (SVR12). * Previous FibroScan measurement (within the last 13 months) between 8 kilopascals and 35 kilopascals. * Able to understand the informed consent form, study procedures and willing to participate in study Exclusion Criteria: * Unable to achieve SVR12 with previous antiviral treatment for HCV * Multiple (\>1) liver disease diagnoses within the past 12 months * Co-infection with another Hepatitis virus or Human Immunodeficiency Virus (HIV), last testing within past 5 years * Documented or known ascites * Documented or known portal hypertension * BMI greater than 35 kg/m2 (30 kg/m2 for optional MRE participants) * If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding * Individuals with history of persistent ethanol abuse (alcohol consumption exceeding 2 standard drinks per day on average \[1 standard drink = 10 grams of alcohol\]) * Individuals with implanted electrical devices such as pacemakers, internal defibrillators, cochlear implants and nerve stimulators. * Individuals with surgically removed gallbladder (for optional MRE procedure only)

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver fatty liver disease fibrotic liver disease hepatitis C virus infection metabolic dysfunction-associated steatohepatitis

As listed by the trial registrant

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

Liver fibrosis Liver steatosis

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • LAIR

    Vancouver, British Columbia, V5Z 1H2, Canada

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