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RECRUITING
NCT06071845
NA

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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

Interventions

DEVICE

Cytosponge Procedure

Investigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.

DIAGNOSTIC_TEST

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