This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE/EAC.
Subjects with known or suspected Barrett's esophagus (BE) (cases)
Patients between the ages of 18-90.
Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
For subjects with or without known evidence of BE (on history or review of medical records)
Pregnant or lactating females.
Patients who are unable to consent.
Patients with current history of uninvestigated dysphagia.
Mayo Clinic
Lead sponsor