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RECRUITING
NCT06687603
NA

Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms

Sponsor: Case Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to develop a method to detect Barrett's esophagus in individuals with a new office based diagnostic test. Barrett's esophagus is a condition in which the flat pink lining of the swallowing tube that connects the mouth to the stomach (the esophagus) becomes damaged by acid reflux. The main question it aims to answer is: Can this approach demonstrate efficacy for screening of Barrett's esophagus? Participants will: * Participate in a questionnaire. * Undergo a capsule balloon test, called EsoCheck. * Have their EsoCheck sample sent to the laboratory for an EsoGuard test, which is used to detect Barrett's esophagus. * Participants will undergo upper endoscopy as part of standard of care.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2025-03-10

Completion Date

2029-09-27

Last Updated

2025-11-13

Healthy Volunteers

Yes

Interventions

DEVICE

EsoCheck

FDA-approved, non-endoscopic, encapsulated swallowable balloon. EsoCheck will produce a sample which will subsequently be tested with EsoGuard assay. The EsoCheck is performed and completed in approximately 5 minutes.

DIAGNOSTIC_TEST

EsoGuard

Approved laboratory, methylated DNA panel that detects esophageal neoplasia. The EsoGuard assay tests the EsoCheck samples to detect BE in GERD participants.

Locations (5)

University of Colorado

Aurora, Colorado, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States