Detecting Barrett's Esophagus with a Non-Endoscopic Device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of the EndoSign® Cell Collection Device in detecting Barrett's Esophagus by collecting esophageal cells non-endoscopically. Participants will swallow a capsule that releases a sponge to collect cells, which will then be tested for methylation biomarkers. The results from the sponge samples will be compared to those obtained from standard endoscopy and biopsies. The study seeks to gather data from individuals at high risk for Barrett's Esophagus based on specific criteria.

Why it matters

Who can join: the full rules

High Risk Screening: Closed November 2025 Barrett's Esophagus Inclusion Criteria

* Undergoing a standard of care EGD (with or without endoscopic eradication therapy {EET})
* Willing to undergo non-endoscopic sampling with the study device prior to EGD (up to 6 weeks prior to EGD/EET or day of EGD/EET).
* Willing and able to sign informed consent
* Confirmed Barrett's Esophagus of length at least 1 cm or greater. This includes non-dysplastic Barrett's, low-grade dysplasia, high-grade dysplasia or adenocarcinoma.

Exclusion Criteria

* Previous EGD result was indefinite for dysplasia
* Previous endoscopic eradication therapy (EET)
* Current dysphagia (unable to swallow a pill the size of the capsule (8.5 mm dia.))
* Known or suspected gastric or esophageal varices
* Known or suspected portal hypertension
* Taking anti-thrombotic medications that cannot be discontinued
* Taking GLP-1 agonists that cannot be discontinued for 1 week prior to sponge administration
* Previous gastric or esophageal surgery (including Nissen fundoplication)
* History of oropharyngeal tumor
* History of myocardial infarction or cerebrovascular accident in past 6 months
* Known or suspected to be pregnant (self-report for woman of child-bearing potential)

Where it's running

• Gastroenterology Practice
  Cordova, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Co-Lead Investigator — University of North Carolina
• Study coordinator: Melissa Tuck, M.S.
• Email: m.tuck@cytedhealth.com
• Phone: 734-358-0587

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.