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Could a simple breath test spot liver cirrhosis early?

NCT ID NCT07035158

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study is testing whether a special drink (EVOC probe) can help detect liver cirrhosis by measuring chemicals in a person's breath. Researchers will compare breath samples from 240 people with and without cirrhosis to build a risk model. The goal is to develop a simple, non-invasive test that could be used in doctor's offices to screen for cirrhosis.

What this could mean

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

Active substance
Libra Oral Solution (EVOC Probe)
What this could lead to
If successful, this could lead to a simple, non-invasive breath test to screen for liver cirrhosis in primary care, reducing the need for more invasive procedures.
What could go wrong
This is an early-stage case-control study (240 participants) to develop a risk model, not a validation trial. The test may not perform well in broader populations or different settings.

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.

Participants

190 people

The number who actually took part.

Started

May 2024

Finished

Jan 2026

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.

Who is studied

Male and female subjects that have a clinical suspicion or diagnosis of cirrhosis

Ages

18 years and older

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: 1. Age ≥ 18 years. 2. Able to provide written informed consent. 3. Clinical suspicion of cirrhosis evaluated in the last six months preceding the recruitment into the study. The presence of clinical suspicion is at the discretion of the (referring) clinician. For reference this will typically be based on (a combination of) the following: * Risk factors: viral hepatitis, metabolic dysfunction associated steatotic liver disease (MASLD), alcoholic liver disease, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, haemochromatosis or combinations of these diseases * Symptoms: e.g. fatigue, weakness, abdominal pain, nausea, vomiting, loss of appetite, oedema, jaundice, spider angioma, palmar erythema, clubbing, gastrointestinal bleeding or altered blood parameters in a liver function test. Exclusion Criteria: 1. Interventional treatment for (underlying cause of) cirrhosis aimed at disease modification during the past six months. Any treatment solely focused on symptom/complications management are permissible. 2. Received an investigational medicinal product in the context of a Clinical Trial (CTIMP) during the 28 days prior to administration of the (first) probe. 3. Women who are pregnant or breastfeeding, for women of childbearing potential a urine pregnancy test can be administered 4. Known allergy/intolerance to any of the constituents of the EVOC-probe cocktail, specifically limonene, 2-butanol, 2-pentanone, polysorbate 80 (aka Tween-80), and sucralose. 5. Subjects on peritoneal- or hemo-dialysis 6. Primary referral for evaluation of the presence of liver cancer (e.g. abnormal findings on imaging). 7. The presence of histopathologically diagnosed liver cancer. 8. (Anticipated) inability to complete the breath sampling procedure due to e.g., inability to maintain adequate ventilation unaided / Inability to comply with the study procedures in the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Arizona Liver Health

    Chandler, Arizona, 85224, United States

  • Hospital Padre Hurtrado

    Santiago, Chile

  • Norfolk and Norwich Hospital

    Norwich, NR4 7UQ, United Kingdom

  • Peterborough City Hospital

    Peterborough, PE3 9GZ, United Kingdom

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