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New ultrasound device could replace costly MRI for liver disease detection

NCT ID NCT04682600

Diagnosis Sponsor: Sonic Incytes Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests a new ultrasound-based device called the Liver Incytes System to see if it can measure liver stiffness and fat as accurately as MRI and FibroScan. The device uses sound waves to create images of the liver, similar to a traditional ultrasound. Researchers are enrolling both healthy volunteers and people with non-alcoholic fatty liver disease (NAFLD) to compare the results from the different methods. If the new device proves reliable, it could offer a simpler and less expensive way to diagnose and monitor liver disease.

What this could mean

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

Active substance
Liver Incytes System (a non-invasive ultrasound-based device that measures liver stiffness and fat using shear wave elastography)
What this could lead to
If successful, this could provide a faster, cheaper, and more accessible way to diagnose and monitor liver fibrosis and steatosis without the need for MRI or biopsy.
What could go wrong
This is a device comparison study, not a treatment trial. The new device may not prove as accurate as MRI or FibroScan, and results may not change clinical practice.

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

164 people

The number who actually took part.

Started

Oct 2020

Finished

Jul 2023

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: * Adults, 19-75 years old * Healthy volunteers or Patients with evidence of NAFLD such as one of the following: Previous liver biopsy consistent with NAFLD OR Evidence of hepatic steatosis on non-invasive assessment by one or more of the following criteria: * Abdominal ultrasound within 12 months * MRI-PDFF (greater than 12%) within 12 month * FibroScan CAP score \> 230 dB/m within 12 months OR At least 2 criteria for metabolic syndrome and increased stiffness on FibroScan (\>8kPa) within 12 months * Able to understand the informed consent form, study procedures and willing to participate in study * If female and of child bearing potential, must agree to practice a highly effective contraception method. Exclusion Criteria: * Active viral hepatitis a. Patients with cured HCV (those with history of treatment and have Sustained Viral Response for 12 weeks (SVR12)) or controlled HBV with no viral detected for more than 6 months are eligible * Decompensated cirrhosis (history of ascites, encephalopathy, or variceal bleeding) * ALT or AST \> 5 x ULN on historical blood work within the past 3 months * BMI greater than 40 kg/m2 (or using cutoff based on MRI) * Other known causes of chronic liver disease * Individuals with history of persistent ethanol abuse (alcohol consumption \> 20g etoh/day for women, \> 40 g etoh/day for men) * Individuals with surgically removed gallbladder * Pregnant or planning to become pregnant while enrolled in this study * Other conditions which would exclude patients from entering an MRI

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver fatty liver disease fibrotic liver disease metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Liver fibroses Liver steatoses Non-alcoholic fatty liver disease (NAFLD) Non-alcoholic steatohepatitis (NASH)

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Centre

    Boston, Massachusetts, 02215, United States

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