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

Non-Endoscopic Detection of Barrett's Esophagus and Esophageal Neoplasia Using Methylation Biomarkers on Endosign® Cell Collection Device Samples

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capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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

Study Overview

• Status: Recruiting
• Conditions: Barrett Esophagus
• Intervention / Treatment: Device: Barrett's Esophagus Test (LDT)

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Keith Fiman, M.D.; Phone Number: 713-305-1074; Email: k.fiman@cytedhealth.com
• Study Contact Backup: Name: Melissa Tuck, M.S.; Phone Number: 734-358-0587; Email: m.tuck@cytedhealth.com

Study Locations

• United States
  • Tennessee
    • Cordova, Tennessee, United States, 38138
      • Recruiting
      • Gastroenterology Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects scheduled for EGD (upper endoscopy) that meet the eligibility criteria at recruiting centers.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Barrett's Esophagus; Subjects with known Barrett's esophagus with or without dysplasia/cancer identified or confirmed (surveillance) via a standard of care endoscopy	Device: 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)
High Risk Screening without Barrett's Esophagus-closed 11/2025; 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.	Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of Barrett's Esophagus Test (LDT) compared to standard of care.	Performance of the biomarker for detecting BE or confirming no BE in the study population including sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) on samples collected using the EndoSign Cell collection device as compared to endoscopy and pathology.	Sample collection prior to standard of care endoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess subject experience with the EndoSign Cell Collection Device	Use of a 10-point scale to assess subject's experience with the device where 0 is no issues and 10 is the worst experience on a number of device-specific questions	Through the end of the study-about 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interim assessment of number of subjects with each diagnosis	At 50% total recruitment to various diagnoses, the Sponsor will evaluate the number of subjects in that cohort with complete clinical data and sample collection. The Sponsor may issue notices to recruiting sites temporarily or permanently closing a cohort to new subjects.	Halfway through the study at about 4 months

Collaborators and Investigators

• Sponsor: Cyted Health Inc
• Investigators: Principal Investigator: Co-Lead Investigator, University of North Carolina; Principal Investigator: Co-Lead Investigator, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): January 31, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Barretts Esophagus; Endosign® Cell Collection Device
• Additional Relevant MeSH Terms: Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: ENDOEXT-28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No