EsoGuard + EsoCheck for Barrett's Esophagus

Recruiting in Cleveland (>99 mi)

+4 other locations

Overseen By Wendy Brock

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Anticoagulants

Disqualifiers: GERD, Esophageal varices, Dysphagia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

800 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Amitabh Chak, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals who may be at risk of Barrett's esophagus but do not have chronic symptoms of gastroesophageal reflux disease (GERD). Participants will answer a questionnaire, undergo the EsoCheck test, and have their samples analyzed with EsoGuard. They must also be willing to have an upper endoscopy.

Inclusion Criteria

I am over 50, can consent, have not had an EGD in 10 years, don't have GERD, and have two risk factors for BE.

I am getting a screening colonoscopy, which qualifies me for BE screening.

I can understand and am willing to sign the consent form.

Exclusion Criteria

I have no medical conditions that prevent me from undergoing esophageal checks or biopsies.

I have had heartburn or acid reflux at least once a week for over five years.

I am on blood thinners that can't be stopped or have a clotting disorder with INR > 1.5.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Testing

Participants undergo a questionnaire, EsoCheck test, and EsoGuard assay to detect Barrett's esophagus

1-2 weeks

1 visit (in-person)

Endoscopy

Participants undergo upper endoscopy as part of standard of care to confirm Barrett's esophagus

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic testing and endoscopy

4 weeks

Treatment Details

Interventions

• EsoCheck
• EsoGuard

Trial Overview The trial is testing the effectiveness of a new office-based diagnostic method using two tests: EsoCheck, a capsule balloon test; and EsoGuard, a laboratory analysis designed to detect Barrett's esophagus in patients without typical GERD symptoms.

Participant Groups

Group I: EsoCheck + EsoGuard Experimental Treatment 2 Interventions

Participants will undergo an EsoCheck test. The sample produced by the EsoCheck will be sent to LucidDx where the EsoGuard assay will be performed.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+