NCT06687603 · Case Comprehensive Cancer Center
Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- History of prior EGD procedure in past ten years
- Inability to provide written informed consent
- History of weekly of more frequent heartburn or regurgitation for five or more years
- On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR \> 1.5
- 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
- Oropharyngeal tumor
- History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure
Where
- Aurora, Colorado
- Baltimore, Maryland
- Chapel Hill, North Carolina
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 13, 2025 · Source of record for eligibility and locations