Detection of Barrett s Esophagus in Patients Without GERD Symptoms
Key facts
- Where
- Cleveland, United StatesSee the site
Where in United States
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, United StatesNo longer taking part
Trial details
- Who runs it
- Case Comprehensive Cancer Center
- Trial code
- NCT04880044
- Record updated
- 10 March 2026
- Original description
The purpose of this study is to develop a method to detect Barrett's esophagus (BE) in individuals with a new office-based diagnostic test.Read full original descriptionShow less
Detection of Barrett s Esophagus in Patients Without Gastroesophageal Reflux Disease (GERD) Symptoms
The purpose of this study is to develop a method to detect Barrett's esophagus (BE) in individuals with a new office-based diagnostic test.
Inclusion: No known coagulopathy, no known esophageal varices; No significant dysphagia or odynophagia; Absence of chronic GERD, defined as five or more years of heartburn or regurgitation with symptoms at least once a week when not on medications for GERD symptoms; Subjects to qualify must meet criterion 3, be over age 50, and have two additional risk factors for BE (white race, central obesity defined as waist size >35 inches for women and >40 inches for men, male gender, current smoker or smoking history >10 pack years, confirmed family history in at least two members with one being a first degree relative).
Exclusion: History of prior EGD procedure; 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 inInvestigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGDprocedure,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 on uncomplicated surgical fundoplication procedure; History of myocardial infarction or cerebrovascular accident within past 6 months; On anti-coagulant drug(s)that cannot be temporarily discontinued or coagulopathy with international normalized ratio (INR) > 1.5; Inability to provide written informed consent; Oropharyngeal tumor.