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New device could diagnose fatty liver without needles

NCT ID NCT02575625

Diagnosis Sponsor: University Hospital, Tours 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a device called Fibroscan can diagnose fatty liver disease (steatosis) without needing a biopsy. Researchers will measure liver stiffness and viscosity in 72 people, including healthy volunteers and patients with confirmed fatty liver. Results will be compared with MRI scans and blood tests to see if Fibroscan is a reliable alternative.

What this could mean

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

What this could lead to
If successful, this could provide a non-invasive way to diagnose fatty liver disease, reducing the need for liver biopsies.
What could go wrong
This is a small, early-stage study with only 72 participants. The method may not be accurate enough to replace current diagnostic tools.

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

72 people

The number who actually took part.

Start date

Apr 2013

Finished

Nov 2015

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 65 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: * Healthy subjects - Steps 1 and 2 * Age between 18 and 65 years old (2 age groups for step 2 : 18-30 et 40-65 years-old) * Written inform consent form signed * Affiliated to medical insurance * Alcohol consumption d'alcool \< 20g/j for women, \<30g/j for men * Patients with liver steatosis - Step 2 * More than 18 years -old * Written inform consent form signed * Affiliated to medical insurance * Patients with clean steatosis confirmed by histological results of a liver biopsy done the previous month * Alcohol consumption d'alcool \< 20g/j for women, \<30g/j for men Exclusion Criteria: * Healthy subjects - Step 1 * Exposure to chemical poisons (solvents, paints, drugs) in the previous 4 weeks * Pregnant women, lactating women, and women in age for procreation and without reliable contraception * Presence of ascites * Person under guardianship * Healthy subjects - Step 2 * Exposure to chemical poisons (solvents, paints, drugs) in the previous 4 weeks * Pregnant women, lactating women, and women in age for procreation and without reliable contraception * Contraindication to MRI * Presence of ascites * Person under guardianship * Healthy subjects - Steps 1 and 2 * Presence of liver tumor or ascites (diagnosed with MRI or ultrasonography) * Abnormal liver function tests (increase of transaminases, gammaGT) * Patients with liver steatosis - Step 2 * Exposure to chemical poisons (solvents, paints, drugs) in the previous 4 weeks * Pregnant women, lactating women, and women in age for procreation and without reliable contraception * Contraindication to MRI * Presence of ascites * liver tumor * Serology anti VHC+ or Ag HBs+ * Infection by HIV * Auto-immun hepatitis * Genetic hemochromatosis, Wilson disease, lake of alpha-1-antitrypsin * Fibrosis or liver cirrhosis at biopsy * Person under guardianship

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Conditions

The condition(s) this trial relates to.

fatty liver disease metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Liver steatosis

Contacts and locations

Locations

  • University Hospital of Tours

    Tours, 37044, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.