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

NCT07490340 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

  • Barrett Esophagus
  • Esophageal Adenocarcinoma
  • Diagnosis

Interventions

DIAGNOSTIC_TEST

trans oral sampling: endosign

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

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2026-04-20
Completion
2026-07-30
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07490340 on ClinicalTrials.gov