Screening for Barretts Esophagus in Adults Over 50 Without Chronic Acid Reflux Symptoms Using EsoCheck and EsoGuard Tests

What this Trial Is About

Researchers are evaluating a new office-based test to detect Barretts esophagus, a condition where the lining of the esophagus is damaged by acid reflux. The study aims to prove if this non-endoscopic screening method can effectively identify Barretts esophagus in individuals without chronic GERD symptoms. Barretts esophagus is important to detect early as it is a precursor to esophageal adenocarcinoma, a highly lethal cancer with poor survival rates. The study involves a swallowable capsule balloon device called EsoCheck, which collects a sample from the esophagus in about five minutes without endoscopy. The sample is then tested in a laboratory using the EsoGuard assay, a DNA-based test to detect Barretts esophagus. Participants will also undergo an upper endoscopy as part of their routine care. The goal is to validate this tests accuracy in a population at risk but without GERD symptoms. Participants will fill out a questionnaire and have their EsoCheck sample collected and sent for analysis. Researchers will monitor the positive predictive value of the test and the prevalence of Barretts esophagus in those who test negative over a period of up to five years. The study includes ongoing assessments of tissue origins for true and false positives. Participation may last several years to capture long-term outcomes and safety data.

Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms