Actively Recruiting
Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms
Led by Case Comprehensive Cancer Center · Updated on 2025-11-13
800
Participants Needed
5
Research Sites
237 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 50 years or older
- No prior upper endoscopy (EGD) within the past 10 years
- Able to provide written informed consent
- No known blood clotting disorders or esophageal varices
- No chronic anticoagulation therapy
- No significant difficulty or pain swallowing (dysphagia or odynophagia)
- Absence of GERD symptoms (no weekly heartburn or regurgitation, not taking GERD medications)
- Presence of at least two risk factors: central obesity (waist > 35 inches for women, > 40 inches for men), current or past smoker with > 10 pack years, white race, male sex, family history of Barrett's esophagus or esophageal adenocarcinoma in at least two relatives including one first degree relative
You will not qualify if you...
- Prior upper endoscopy (EGD) within the past 10 years
- Unable to provide written informed consent
- Weekly or more frequent heartburn or regurgitation symptoms lasting 5 or more years
- Use of anticoagulant drugs that cannot be temporarily stopped or coagulopathy with INR > 1.5
- Known esophageal varices or esophageal strictures
- Any medical reason deemed by the investigator that prevents undergoing EsoCheck, endoscopy, or biopsies, including coagulopathy, esophageal diverticula, fistula, or ulceration
- History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including difficulty swallowing pills
- Presence of oropharyngeal tumors
- History of esophageal or gastric surgery except uncomplicated fundoplication procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
3
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 027599
Actively Recruiting
4
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44016
Actively Recruiting
5
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
Research Team
W
Wendy Brock
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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