Actively Recruiting
Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples
Led by Cyted Health Inc · Updated on 2026-03-18
700
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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a capsule, which dissolves in the stomach and releases a sponge that collects cells from the esophagus as the sponge is withdrawn using the thread.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.
CONDITIONS
Official Title
Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing a standard of care endoscopy (EGD) with or without endoscopic eradication therapy
- Willing to have non-endoscopic sampling with the study device before endoscopy (up to 6 weeks before or on the day of procedure)
- Willing and able to sign informed consent
- Confirmed Barrett's Esophagus of 1 cm length or greater, including non-dysplastic, low-grade dysplasia, high-grade dysplasia, or adenocarcinoma
You will not qualify if you...
- Previous endoscopy result was indefinite for dysplasia
- Previous endoscopic eradication therapy
- Current difficulty swallowing a pill the size of the capsule (8.5 mm diameter)
- Known or suspected gastric or esophageal varices
- Known or suspected portal hypertension
- Taking anti-thrombotic medications that cannot be stopped
- Taking GLP-1 agonists that cannot be stopped for 1 week before sponge use
- Previous gastric or esophageal surgery including Nissen fundoplication
- History of oropharyngeal tumor
- History of heart attack or stroke in the past 6 months
- Known or suspected pregnancy (for women who can become pregnant)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gastroenterology Practice
Cordova, Tennessee, United States, 38138
Actively Recruiting
Research Team
M
Melissa Tuck, M.S.
CONTACT
K
Keith Fiman, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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