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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About 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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form, 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 willing to sign a consent form document. - Subjects must have the ability to understand and the willingness to sign a written willing to sign a consent form document. Who Should NOT Join This Trial: - History of prior EGD procedure in past ten years - Inability to provide written willing to sign a consent form - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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