Detecting Barrett's Esophagus with a Non-Endoscopic Device
Non-Endoscopic Detection of Barrett's Esophagus and Esophageal Neoplasia Using Methylation Biomarkers on Endosign® Cell Collection Device Samples
This study is testing a new capsule device that collects cells from the esophagus to see if it can effectively detect Barrett's Esophagus in people at high risk, without needing an endoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cyted Health Inc Industry-sponsored |
| Locations | 1 site (Cordova, Tennessee) |
| Trial ID | NCT06803927 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with chronic GERD and at least three additional risk factors for Barrett's Esophagus.
Not a fit: Patients with known Barrett's Esophagus or esophageal adenocarcinoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive method for detecting Barrett's Esophagus, potentially improving patient comfort and access to screening.
How similar studies have performed: While this approach is innovative, similar studies using non-endoscopic methods for Barrett's Esophagus detection have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cordova, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.