NCT06803927 Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples
| NCT ID | NCT06803927 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cyted Health Inc |
| Condition | Barrett Esophagus |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2025-02-05 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 700 participants in total. It began in 2025-02-05 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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
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)
Contact & Investigator
Co-Lead Investigator
PRINCIPAL INVESTIGATOR
University of North Carolina
Frequently Asked Questions
Who can join the NCT06803927 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Barrett Esophagus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06803927 currently recruiting?
Yes, NCT06803927 is actively recruiting participants. Contact the research team at m.tuck@cytedhealth.com for enrollment information.
Where is the NCT06803927 trial being conducted?
This trial is being conducted at Cordova, United States.
Who is sponsoring the NCT06803927 clinical trial?
NCT06803927 is sponsored by Cyted Health Inc. The principal investigator is Co-Lead Investigator at University of North Carolina. The trial plans to enroll 700 participants.