Could a simple breath test spot liver cirrhosis early?
NCT ID NCT07035158
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cirrhosis, liver are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New blood panel aims to catch liver cancer before it spreads
- Spleen surgery may reshape cholesterol in cirrhosis
- Spleen surgery and kidney health: a hidden connection in cirrhosis?
- Decade-Long study aims to unlock liver disease risks in HIV-Hepatitis b patients
- Zambia study tracks hepatitis b outcomes in hundreds of patients
- New study tracks blood sugar in liver disease patients on common drug