Trans-Oral Sampling as an Alternative Surveillance of Barrett's Esophagus Pilot

The study aims to address the increasing incidence of esophageal cancer and Barrett's esophagus (BE) in the Western world by exploring a more efficient surveillance method. Esophageal adenocarcinoma (EAC) has a poor prognosis if diagnosed late, emphasizing the need for early detection strategies. Current surveillance methods, involving regular endoscopies, are burdensome and costly, particularly for low-risk patients. The study investigates the potential of the Endosign, a Trans Oral Sampling (TOS) device, as an alternative to endoscopic surveillance. The objective is to determine if Endosign can provide sufficient quality samples, containing columnar cells and clot preparations at least 5mm in size, thus offering a reliable substitute for endoscopic sampling. The study includes non-dysplastic and dysplastic BE patients undergoing surveillance or treatment and employs a single-center, prospective feasibility approach.

NCT Number	NCT07490340
Lead Sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions	Barrett Esophagus, Esophageal Adenocarcinoma, Diagnosis
Enrollment	60 participants
Start Date	2023-10-20
Primary Completion	2026-04-20 (estimated)
Study Completion	2026-07-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-24