RecruitingNCT06803927

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

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


Sponsor

Cyted Health Inc

Enrollment

700 participants

Start Date

Feb 5, 2025

Study Type

OBSERVATIONAL

Conditions

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capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a non-invasive swallowable device to detect Barrett's esophagus — a condition where the lining of the food pipe changes, which can sometimes lead to cancer — without needing a traditional camera scope procedure. **You may be eligible if...** - You have already been diagnosed with Barrett's esophagus (at least 1 cm long), including cases with or without early cell changes - You are scheduled for a standard endoscopy procedure - You are willing to swallow the study device before your endoscopy **You may NOT be eligible if...** - Your previous endoscopy result was unclear about whether abnormal cells were present - You have already had endoscopic treatment to remove Barrett's tissue - You have trouble swallowing (unable to swallow a small capsule about the size of a large pill) - You have or may have varicose veins in your esophagus or stomach - You take blood-thinning medications that cannot be stopped - You take GLP-1 medications (like Ozempic) that cannot be paused for 1 week - You have had prior surgery on your stomach or esophagus - You had a heart attack or stroke in the past 6 months - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBarrett'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)


Locations(1)

Gastroenterology Practice

Cordova, Tennessee, United States

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NCT06803927


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