Non-Endoscopic Detection of Barrett's Esophagus and Esophageal Neoplasia Using Methylation Biomarkers on Endosign® Cell Collection Device Samples
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Performance of Barrett's Esophagus Test (LDT) compared to standard of care.
Study Overview
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a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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)
Arms & Interventions
Barrett's Esophagus
Subjects with known Barrett's esophagus with or without dysplasia/cancer identified or confirmed (surveillance) via a standard of care endoscopy
Intervention: Barrett's Esophagus Test (LDT) (Device)
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.
Intervention: Barrett's Esophagus Test (LDT) (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Assess subject self-reported experience with the EndoSign Cell Collection Device(At the Baseline Visit)
- Proportion of Subjects meeting Sample Assay Requirements(At study completion, about 1.5 years)
- Performance of BE Test by Prague, Histopathology grade and Seattle Protocol Adherence.(Sample collection prior to standard of care endoscopy)