Testing a Minimally Invasive Sponge Capsule Device to Detect Barretts Esophagus and Esophageal Adenocarcinoma Using Molecular Markers

What this Trial Is About

Researchers are evaluating a minimally invasive molecular method to detect Barretts Esophagus and esophageal adenocarcinoma using a sponge capsule device. The study aims to assess the accuracy of this device in screening people with and without chronic gastroesophageal reflux disease, including those at risk or with a diagnosis of Barretts Esophagus. This approach focuses on detecting methylated DNA markers from esophageal cells collected by the device. Participants will swallow the sponge capsule, which collects esophageal cells for analysis. The procedure will be performed by trained non-physicians like nurses. Study groups include people with gastroesophageal reflux or other risk factors, those diagnosed with Barretts Esophagus scheduled for upper endoscopy, and those without Barretts Esophagus also scheduled for endoscopy. Some participants will also undergo biopsies and brushings during endoscopy. During the study, participants will complete questionnaires and undergo the sponge capsule procedure, and those undergoing endoscopy will have additional tissue sampling for comparison. Researchers will measure the sensitivity and specificity of the device to detect Barretts Esophagus and dysplasia over five years. Safety, tolerability, and predictive value of the sponge capsule procedure will also be monitored. The study duration includes follow-up assessments over five years to evaluate outcomes.

Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma