Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms
Sponsor: Case Comprehensive Cancer Center • ClinicalTrials.gov ID: NCT06687603
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The goal of this clinical trial is to develop a method to detect Barrett's esophagus in individuals with a new office based diagnostic test. Barrett's esophagus is a condition in which the flat pink lining of the swallowing tube that connects the mouth to the stomach (the esophagus) becomes damaged by acid reflux. The main question it aims to answer is: Can this approach demonstrate efficacy for screening of Barrett's esophagus? Participants will: * Participate in a questionnaire. * Undergo a capsule balloon test, called EsoCheck. * Have their EsoCheck sample sent to the laboratory for an EsoGuard test, which is used to detect Barrett's esophagus. * Participants will undergo upper endoscopy as part of standard of care.
Interventions
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EsoCheck
(Device)
FDA-approved, non-endoscopic, encapsulated swallowable balloon. EsoCheck will produce a sample which will subsequently be tested with EsoGuard assay. The EsoCheck is performed and completed in approximately 5 minutes.
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EsoGuard
(Diagnostic test)
Approved laboratory, methylated DNA panel that detects esophageal neoplasia. The EsoGuard assay tests the EsoCheck samples to detect BE in GERD participants.
Eligibility criteria
Conditions
Locations
- University of Colorado — Aurora, Colorado, United States
- Johns Hopkins Hospital — Baltimore, Maryland, United States
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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