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

July 27, 2026 updated by: Cyted Health Inc

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capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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.
Time Frame: Sample collection prior to standard of care endoscopy
Performance of the biomarker for detecting BE or confirming no BE in the study population. Sensitivity and specificity are co-primary endpoints. Samples are collected using the EndoSign Cell collection device, tested in a CLIA lab and compared to endoscopy/pathology diagnosis confirmed by independent central pathology review.
Sample collection prior to standard of care endoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess subject self-reported experience with the EndoSign Cell Collection Device
Time Frame: At the Baseline Visit
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
At the Baseline Visit
Proportion of Subjects meeting Sample Assay Requirements
Time Frame: At study completion, about 1.5 years
Proportion of subjects among those with cell samples obtained and sent to the central laboratory for processing with DNA yield as well as QC pass of the sequencing process by applying thresholds specified in the laboratory's CLIA/CAP documentation.
At study completion, about 1.5 years
Performance of BE Test by Prague, Histopathology grade and Seattle Protocol Adherence.
Time Frame: Sample collection prior to standard of care endoscopy

Sensitivity by histopathological grade: NDBE, all BE with neoplasia or EAC, and separately for indefinite for dysplasia (IND), low grade dysplasia (LGD), high grade dysplasia (HGD) / intramucosal carcinoma (IMC), and EAC.

Sensitivity by length of BE segment. Short-segment BE is defined as <3 cm in length . Long-segment BE is defined as 3 cm or longer.

Sensitivity and specificity of the Barrett's Esophagus Test in the subgroup entering via the HRS pathway.

Sensitivity and Specificity based on adherence to the Seattle biopsy Protocol Lack of adherence to the Seattle biopsy protocol (defined as either: 1) <1 specimen jar per 2 cm of BE and/or 2) lack of documentation of adhering to the biopsy protocol) is common and may impact detection of true positive BE patients. Sensitivity and specificity will be dichotomized by Seattle protocol status, and false positive cases will be compared to true positives for adherence to the protocol.
Sample collection prior to standard of care endoscopy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interim assessment of number of subjects with each diagnosis
Time Frame: Halfway through the study at about 4 months
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
Characterize the safety profile of the EndoSign Cell Collection Device as used in this study by noting the frequency and severity of adverse events or adverse device effects related to the device administration.
Time Frame: At Baseline Visit
Characterize the safety profile of the EndoSign Cell Collection Device as used in this study by noting the frequency and severity of adverse events or adverse device effects related to the device administration. Assessed by subject self-report per discharge instructions, urgent care or ER visit, call to treating or research physician.
At Baseline Visit
Positive and Negative Predictive values as an additional, but not primary endpoint.
Time Frame: Sample collection prior to standard of care endoscopy
Positive Predictive Value (the proportion of subjects who have Barrett's Esophagus among subjects with positive test results, PPV) and Negative Predictive Value (the proportion of subjects who do not have Barrett's Esophagus among subjects with negative test results, NPV) among the subset of patients entering the study via the high-risk screening pathway will be computed to complement the information provided by sensitivity and specificity.
Sample collection prior to standard of care endoscopy
Demographic and other Descriptive Summaries
Time Frame: At Baseline visit
Categorical variables (such as race, ethnicity, or whether a patient has BE) generally will be summarized using frequencies and proportions or percentages, while continuous variables (such as age or BE segment length) generally will be summarized using means, standard deviations (SDs), and/or medians and quartiles or ranges. When summarizing continuous variables, no confirmed values, outside allowable ranges or otherwise, will be considered outliers. Missing values generally will be reported as such in descriptive summaries.
At Baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 27, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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