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

NCT ID: NCT06803927

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2026-01-31

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a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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.

Conditions

Barrett Esophagus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

High Risk Screening without Barrett's Esophagus

Subjects with chronic GERD plus 3 other defined risk factors for Barrett's Esophagus (ACG) (e.g., age \>50, male, white, obese, family history) who have had a standard of care endoscopy in which no Barrett's esophagus was identified.

Barrett's Esophagus Test (LDT)

Intervention Type: DEVICE

Barrett's Esophagus Test (LDT) will be performed on esophageal cells collected using the EndoSign Cell Collection Device (510(k) cleared) and compared to the results of standard of care EGD plus biopsies (if applicable)

Barrett's Esophagus

Subjects with known Barrett's esophagus with or without dysplasia/cancer identified or confirmed (surveillance) via a standard of care endoscopy

Barrett's Esophagus Test (LDT)

Intervention Type: DEVICE

Barrett's Esophagus Test (LDT) will be performed on esophageal cells collected using the EndoSign Cell Collection Device (510(k) cleared) and compared to the results of standard of care EGD plus biopsies (if applicable)

Interventions

Barrett's Esophagus Test (LDT)

Barrett's Esophagus Test (LDT) will be performed on esophageal cells collected using the EndoSign Cell Collection Device (510(k) cleared) and compared to the results of standard of care EGD plus biopsies (if applicable)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Undergoing a standard of care EGD
• Willing to undergo non-endoscopic sampling with the study device prior to EGD (up to 6 weeks prior to EGD or same day as EGD).
• Willing and able to sign informed consent
• Must have chronic GERD as defined in the ACG Guidelines
• Must have at least 3 additional risk factors as defined in the ACG guidelines such as:
• Age ≥ 50
• Family history of Barrett's esophagus or esophageal adenocarcinoma
• Current or former smoker
• Obesity (BMI greater than or equal to 30 kg/m2)
• Male
• Non-Hispanic White

• 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 for BE, with no BE identified
• Known BE or EAC
• Current dysphagia (unable to swallow a pill the size of the capsule (8.5 mm diameter))
• 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 women of child-bearing potential)

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cyted Health Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Co-Lead Investigator

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Co-Lead Investigator

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Gastroenterology Practice

Cordova, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Melissa Tuck, M.S.

Role: CONTACT

m.tuck@cytedhealth.com

734-358-0587

Keith Fiman, M.D.

Role: CONTACT

k.fiman@cytedhealth.com

713-305-1074

Other Identifiers

ENDOEXT-28

Identifier Type: -

Identifier Source: org_study_id