IRB Study Number 25-641
Status Recruiting
Institute Digestive Disease & Surgery Institute
Description
The purpose of this study is to develop a method to detect Barrett’s esophagus in individuals who have some risk factors for developing it 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. It is associated with an increased risk of developing esophageal cancer. Your participation in this study will include your completion of a questionnaire and additionally, you will undergo the performance of the EsoCheck procedure to donate tissue for the Eso guard Assay to analyze your tissue sample and a possible voluntary upper endoscopy.
Inclusion Criteria
- 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.
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
