DELIVER Study in a Population With Clinical Suspicion of Liver Cirrhosis
Key facts
- Who runs it
- Owlstone Ltd
- Where
- Chandler, United StatesSee the siteAlso in 2 other countries, 3 sites
- Trial code
- Status
- Completed
- People taking part
- 190 people enrolled
- Started
- 10 May 2024
- Ended
- 29 Jan 2026
- Type of study
- Observational
- Treatments tested
- Libra Oral Solution
- Record updated
- 9 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Age ≥ 18 years
- Able to provide written informed consent
- 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
Who cannot take part
- Received an investigational medicinal product in the context of a Clinical Trial (CTIMP) during the 28 days prior to administration of the (first) probe
- 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
- 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
- Primary referral for evaluation of the presence of liver cancer (e.g. abnormal findings on imaging)
- The presence of histopathologically diagnosed liver cancer
- Women who are pregnant or breastfeeding, for women of childbearing potential a urine pregnancy test can be administered
- Subjects on peritoneal- or hemo-dialysis
- (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
Where in United States
Also in 2 other countries, 3 sites
- Arizona Liver HealthChandler, United States
About the trial
What the trial wants to find out
Owlstone Medical has demonstrated that the use of an Exogenous Volatile Organic Compound (EVOC) that targets specific metabolic processes linked to cirrhosis pathophysiology enables identification of subjects with cirrhosis with high accuracy compared to healthy controls. This approach relies on the oral administration of food additives that are metabolized in the liver resulting in volatile end-products exhaled in breath. The presence of liver cirrhosis alters the metabolism of these EVOC-probes altering the breath concentrations of the end-products. These alterations can be used to identify subjects who have a risk of having liver cirrhosis.
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The study is designed as a case control study comparing subjects with cirrhosis against controls originating from a group of subjects with clinical suspicion of cirrhosis. Adequate balancing of subjects across definitive, probable, possible, and absent cirrhosis groups will be assured through a recruitment enrichment strategy. The primary output of the study will be an algorithm to calculate a risk score for the presence of cirrhosis. As a secondary objective sensitivity analysis will be performed to assess the impact of subject characteristics and cirrhosis etiology on test performance to assure robustness of the test in a deployment setting. The results of this study will inform test optimization for a prospective clinical validation trial, with the goal of developing a test that is widely applicable and available in primary care centers
The group in the trial
- EVOC probe
After confirming full eligibility, the EVOC probe will be administered orally to both cases (individuals with cirrhosis) and controls (individuals with a clinical suspicion of cirrhosis)
Treatment: Libra Oral Solution
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Case Control Study in a Population With Clinical Suspicion of Liver Cirrhosis to Develop a Risk Model for the Presence of Cirrhosis Using Breath Biomarkers/EVOC Probes
- Record updated
- 9 July 2026