Status:
COMPLETED
Detection of Barrett s Esophagus in Patients Without GERD Symptoms
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Barrett's Esophagus
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
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.
Detailed Description
This study will investigate whether using EsoCheck/EsoGuard(EC/EG) can detect BE in individuals at risk for BE who are currently not being detected and are not undergoing routine esophago-gastro-duode...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2025
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04880044
Start Date
January 5 2022
End Date
February 25 2025
Last Update
August 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065