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Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
Sponsor: Mayo Clinic
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2023-10-16
Completion Date
2026-06-01
Last Updated
2025-12-16
Healthy Volunteers
No
Conditions
Interventions
Cytosponge Procedure
Investigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.
Endoscopic Assessment
Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
Locations (5)
Mayo Clinic
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Long Island Jewish Medical Center | Northwell Health
New Hyde Park, New York, United States