Detection of Barrett s Esophagus in Patients Without GERD Symptoms
Completed · Not applicable
Conditions studied: Barrett's Esophagus
In brief
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.
Key facts
- Study ID
- NCT04880044
- Run by
- Case Comprehensive Cancer Center
- People needed
- 132
- Starts
- 2022-01-05
- Expected to finish
- 2025-02-25
- Last updated by the study team
- 2026-03-10
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- History of prior EGD procedure
- 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 international normalized ratio (INR) > 1.5
- 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
- Oropharyngeal tumor
- History of esophageal or gastric surgery, with exception on uncomplicated surgical fundoplication procedure
- History of myocardial infarction or cerebrovascular accident within past 6 months
Where it is running
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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