RecruitingNot ApplicableNCT06071845

Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples

Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia

Sponsor

Mayo Clinic

Enrollment

400 participants

Start Date

Oct 16, 2023

Study Type

INTERVENTIONAL

Conditions

Esophageal Adenocarcinoma Barrett Esophagus Barretts Esophagus With Dysplasia Barrett's Esophagus Without Dysplasia

Summary

This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE/EAC.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a minimally invasive swallowable device that collects cells from the esophagus (food pipe) to test for Barrett's esophagus — a condition where the lining of the esophagus changes and can increase cancer risk. The device offers an alternative to traditional endoscopy for screening. **You may be eligible if...** - You are between 18 and 90 years old - You have a known or suspected diagnosis of Barrett's esophagus, OR - You are undergoing routine diagnostic endoscopy without a history of Barrett's esophagus - You are already scheduled for a clinically recommended endoscopy **You may NOT be eligible if...** - You have had surgery on your esophagus or upper stomach previously - You have active esophageal bleeding or very severe narrowing - You have certain swallowing disorders that would make using the device unsafe - You are unable to give informed consent 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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