DELIVER Study in a Population With Clinical Suspicion of Liver Cirrhosis

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Owlstone Ltd
Study ID
NCT07035158
Status
Recruiting
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Conditions

  • Cirrhosis, Liver

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Libra Oral Solution — DIAGNOSTIC_TEST
    EVOC Probe

Study Details

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. 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

Key Dates

Start date
May 10, 2024
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
240 participants (estimated)

Arms

  • Arm: 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)

Primary Outcome Measure

Developing a model to determine the risk of the presence of liver cirrhosis. [ Time Frame: 10 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Arizona Liver HealthChandlerArizona85224
Jessica Omaña Castañeda
[email protected]
+1 480-470-4000

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By research site
Arizona Liver Health· Chandler, AZ

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