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NCT07035158 · ClinicalTrials.gov registry record
DELIVER Study in a Population With Clinical Suspicion of Liver Cirrhosis
A clinical trial of Cirrhosis, Liver, sponsored by Owlstone.
- Recruiting
- Registry status
- 240
- Enrollment target
- 4
- Study locations
NCT07035158 is a study of Cirrhosis, Liver that is actively recruiting participants, run by Owlstone. The registered enrollment target is 240 participants, roughly in line with the 235-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target. The trial reports 4 study locations across 2 states.
The verdict
NCT07035158, a study of Cirrhosis, Liver, is actively recruiting participants, sponsored by Owlstone.
- RECRUITING
- Registry status
- 240 participants
- Enrollment target
- 4
- Study locations
Study Summary
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
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Libra Oral Solution
Study Locations (4)
Other
- Hospital Padre Hurtrado - Santiago
- Norfolk and Norwich Hospital - Norwich
- Peterborough City Hospital - Peterborough
Arizona
- Arizona Liver Health - Chandler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2024-05-10 |
| Est. Completion | 2025-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07035158
The ClinicalTrials.gov registry entry for NCT07035158 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 235-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target. The listed sponsor is Owlstone, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cirrhosis, Liver appearing as the primary indexed condition, and to 1 intervention - of which Libra Oral Solution is the first listed.
NCT07035158 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Other, Arizona.
Frequently Asked Questions
What is clinical trial NCT07035158 about?
NCT07035158 is a clinical study titled "DELIVER Study in a Population With Clinical Suspicion of Liver Cirrhosis". 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...
What is the current status of trial NCT07035158?
This trial is currently recruiting. The enrollment target is 240 participants. The study started on 2024-05-10. Estimated completion is 2025-12.
What conditions does trial NCT07035158 study?
This clinical trial studies the following conditions: Cirrhosis, Liver.
What interventions are being tested in trial NCT07035158?
The interventions under investigation include: Libra Oral Solution (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07035158?
This trial is sponsored by Owlstone, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07035158 being conducted?
This trial has 4 study locations across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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