Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples

Last updated: March 16, 2026
Sponsor: Cyted Health Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Treatment

Barrett's Esophagus Test (LDT)

Clinical Study ID

NCT06803927
ENDOEXT-28
  • Ages > 18
  • All Genders

Study Summary

This study is looking at cells collected from the esophagus using a diagnostic device called the EndoSign® Cell Collection Device (a sponge on a thread). Subjects swallow a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread. These cells will be tested to check for a condition called "Barrett's Esophagus."

The cells from the sponge will be tested using Cyted Health biomarkers and compared to the results from a regular endoscopy and any biopsies that are taken. To do this, we need sponge samples from people who might have Barrett's Esophagus based on their risk factors, and from people with Barrett's Esophagus.

Subjects will have one visit to have the Endosign Cell Collection Device administered prior to having a standard of care endoscopy. They will answer some questions about their medical history and experience with the cell collection procedure as part of the study. Data will be collected from medical records including post-endoscopy.

Eligibility Criteria

Inclusion

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)

Study Design

Total Participants: 700
Treatment Group(s): 1
Primary Treatment: Barrett's Esophagus Test (LDT)
Phase:
Study Start date:
February 05, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Gastroenterology Practice

    Cordova, Tennessee 38138
    United States

    Active - Recruiting

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