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

Launched by CYTED HEALTH INC · Jan 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to detect a condition called Barrett's Esophagus, which can develop in people with ongoing acid reflux. The researchers are using a special device called the EndoSign® Cell Collection Device, which is a small sponge attached to a thread that collects cells from the esophagus. Participants will swallow a capsule that releases the sponge, allowing it to gather cells as it is pulled back out. These cells will then be tested for signs of Barrett's Esophagus and compared to results from a standard procedure called an endoscopy, where a doctor looks inside the esophagus.

To participate, individuals need to be at high risk for Barrett's Esophagus, which means they should have chronic acid reflux and at least three additional risk factors, such as being over 50 years old, having a family history of Barrett's Esophagus, or being obese. Participants will have one visit to use the EndoSign device before undergoing an endoscopy, and they will answer questions about their medical history and experience with the device. If you or someone you know fits these criteria and is interested, this trial could provide valuable information on a non-invasive way to detect Barrett's Esophagus.

Gender

ALL

Eligibility criteria

• • High Risk Screening Inclusion Criteria
• • Undergoing a standard of care EGD
• • Willing to undergo non-endoscopic sampling with the study device prior to EGD (up to 6 weeks prior to EGD or same day as EGD).
• • Willing and able to sign informed consent
• • Must have chronic GERD as defined in the ACG Guidelines
• * Must have at least 3 additional risk factors as defined in the ACG guidelines such as:
• • Age ≥ 50
• • Family history of Barrett's esophagus or esophageal adenocarcinoma
• • Current or former smoker
• • Obesity (BMI greater than or equal to 30 kg/m2)
• • Male
• • Non-Hispanic White
• • Exclusion Criteria
• • Previous EGD for BE, with no BE identified
• • Known BE or EAC
• • Current dysphagia (unable to swallow 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 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 women of child-bearing potential)
• • 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)