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

Condition(s) studied

Investigational drug(s) / intervention(s)

trans oral sampling: endosign: the endosign samples the esophagus by pulling the string on a sponge

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.

Eligibility

Primary outcome measure(s)

• to determine the number of sufficient quality samples obtained through the use of the Endosign, which could potentially serve as a substitute for endoscopic sampling. — 1year
  The amount of samples collected with the Endosign that contain columnar cells and are processed to clot preparations that are at least 5mm in size.

Trial sites (1)

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