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

Official record

Identifier

NCT06803927

Recruiting locations

country

United States

Interventions studied

Barrett's Esophagus Test (LDT)

Lead sponsor

Cyted Health Inc

Target enrolment

700 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Recruiting

First posted

Jan 31, 2025

Last updated on the registry

Jul 29, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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)

Indexed under

Esophageal Cancer