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NCT07490340

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

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

Summary

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.

Official title: Trans-Oral Sampling as an Alternative Surveillance of Barrett's Esophagus Pilot: TOSS Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2023-10-20

Completion Date

2026-07-30

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

trans oral sampling: endosign

the endosign samples the esophagus by pulling the string on a sponge

Locations (1)

Amsterdam University Medical Centre, loc. VUmc

Amsterdam, North Holland, Netherlands