RecruitingNot ApplicableNCT06720636

Ultralong-segment Barrett's Esophagus: Towards a Capsule-sponge Surveillance Strategy


Sponsor

Erasmus Medical Center

Enrollment

137 participants

Start Date

Feb 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the Endosign capsule sponge test as a novel surveillance method in patients with an ultralong-segment Barrett's esophagus.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is developing a new, less invasive way to monitor very long stretches of Barrett's esophagus — a condition where the lining of the esophagus (food pipe) changes due to chronic acid reflux and can sometimes lead to cancer. The study tests whether a swallowed capsule-sponge device can be used for surveillance instead of a traditional endoscopy. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with ultralong-segment Barrett's esophagus (a very extensive area of abnormal lining) - You are medically fit to undergo a standard endoscopy - You are able to give informed consent **You may NOT be eligible if...** - You have been diagnosed with throat, esophageal, or stomach cancer (stage T2 or above) - You have difficulty swallowing (dysphagia) - You have esophageal varices (enlarged veins in the esophagus) or a stricture that needs dilation - You had a stroke in the last 6 months affecting your ability to swallow - You have previously had certain esophageal treatments (photodynamic therapy, radiofrequency ablation, or argon plasma coagulation) for precancerous Barrett's Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEndoSign

The EndoSign cell collection device is a non-endoscopic capsule sponge device used to collect pan-esophageal samples. The Endosign procedure consists of an expandable, spherical mesh, which is attached to a string and contained within a soluble capsule. Seven minutes after swallowing (once the capsule has dissolved), the spherical mesh, which measures around 3cm in diameter is retrieved by pulling on the string. Upon retrieval the capsule-sponge scrapes against the surface of the top of the stomach and esophagus and collects epithelial cells. The capsule-sponge sample is then placed into a preservative fluid and the specimen is processed for molecular tests.


Locations(1)

Erasmus Medisch Centrum

Rotterdam, South Holland, Netherlands

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NCT06720636


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