Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms
Key facts
- Who runs it
- Case Comprehensive Cancer Center
- Where
- Aurora, Baltimore, Chapel Hill, and Cleveland, United StatesSee the 5 sites
- Trial code
- Status
- Recruiting
- People taking part
- 800 people, planned
- Started
- 10 Mar 2025
- Expected to end
- 27 Sept 2029
- Type of study
- Interventional
- Treatments tested
- EsoCheck
- EsoGuard
- Record updated
- 15 September 2026
Who can take part
- Age
- 50 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Patients undergoing screening colonoscopy are an accessible cohort for BE screening and are also a reasonable representation of the general population. Permission will be obtained from colonoscopy physicians for researchers to contact and recruit patients for this study. Patients without GERD, who are at risk for BE, and who have not had a prior EGD, will be recruited prior to or at the time of scheduled colonoscopy.(9) Those eligible will be:
- Adults who have not had prior EGD within past ten years, and are able to provide informed consent, and who have:
- No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:
- No significant dysphagia or odynophagia; but who do have:
- Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:
- Adults > age 50, who also have two or more added risk factors for BE from the set of: central obesity (waist size > 35 inches for women and > 40 inches for men), current smoker or smoking history > 10 pack years, white race, male sex, confirmed history of BE/EAC in at least two family members, with one a first degree relative. While BE is most highly prevalent in white males, a black female over age 50 with obesity and a positive smoking history would also be at increased BE risk and would equally meet eligibility criteria
- Subjects must have the ability to understand and the willingness to sign a written informed consent document
- Subjects must have the ability to understand and the willingness to sign a written informed consent document
Who cannot take part
- History of prior EGD procedure in past ten years
- History of weekly of more frequent heartburn or regurgitation for five or more years
- Known history of esophageal varices or esophageal stricture
- Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
- History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
- History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
- On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR > 1.5
- Inability to provide written informed consent
- Oropharyngeal tumor
Where in United States
- University of ColoradoAurora, United StatesContact: Sachin Wani, MDTaking people
- Johns Hopkins HospitalBaltimore, United StatesContact: Marcia Canto, MDTaking people
- University of North Carolina at Chapel HillChapel Hill, United StatesContact: Nicholas Shaheen, MDTaking people
- Cleveland Clinic Taussig Cancer CenterCleveland, United StatesContact: Prashanti Thota, MDTaking people
- University Hospitals Cleveland Medical Center*Cleveland, United StatesContact: Amitabh Chak, MDTaking people
About the trial
What the trial wants to find out
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?
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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.
The group in the trial
- EsoCheck + EsoGuardTreatment being tested
Participants will undergo an EsoCheck test. The sample produced by the EsoCheck will be sent to LucidDx where the EsoGuard assay will be performed.
Treatment: EsoCheck and EsoGuard
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 15 September 2026