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

Part of paid clinical trials in Cordova, Tennessee.

Sponsor
Cyted Health Inc
Study ID
NCT06803927
Status
Recruiting
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Conditions

  • Barrett Esophagus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Barrett's Esophagus Test (LDT) — 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)

Study Details

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capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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

Key Dates

Start date
Feb 5, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
700 participants (estimated)

Arms

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

Primary Outcome Measure

Performance of Barrett's Esophagus Test (LDT) compared to standard of care. [ Time Frame: Sample collection prior to standard of care endoscopy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Gastroenterology PracticeCordovaTennessee38138-

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Gastroenterology Practice· Cordova, TN

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