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

Recruiting

• Conditions: Barrett Esophagus

• Registration Number: NCT06803927
• Lead Sponsor: Cyted Health Inc

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capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-28
• Study First Posted: 2025-01-31
• Study Start: 2025-02-05
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-21
• Primary Completion: 2025-12-30
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of Barrett's Esophagus Test (LDT) compared to standard of care.	Sample collection prior to standard of care endoscopy	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.

Secondary Outcome Measures

Name	Time	Method
Assess subject experience with the EndoSign Cell Collection Device	Through the end of the study-about 9 months	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

Trial Locations

Locations (1)

Gastroenterology Practice; 🇺🇸 Cordova, Tennessee, United States