Status:
UNKNOWN
Non-endoscopic Esophageal Sampling to Detect Barrett's Esophagus and Esophageal Cancer in Veterans
Lead Sponsor:
Louis Stokes VA Medical Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Barrett Esophagus
GERD
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief Summary
This study seeks to incorporate non-endoscopic detection method (Esocheck/Esoguard) in primary care practice and test whether this screening modality increases the positive predictive value of upper e...
Detailed Description
This study addresses prevention and early detection of esophageal adenocarcinoma (EAC). Prospectively collected Surveillance Epidemiology and End Results (SEER) data indicate that the incidence of eso...
Eligibility Criteria
Inclusion
- Patients who have symptomatic GERD and also meet criteria for upper endoscopic screening for BE will be accrued. Eligible patients will include:
- Adult Veterans \> 40 and \< 85 years old who have no prior EGD and can provide informed consent
- No known coagulopathy, no known esophageal varices.
- No significant dysphagia or odynophagia
- Documented GERD or use of proton pump inhibitors (PPIs) for \> 5 years
- Meet ACG Clinical Guideline criteria for BE screening (that require presence of multiple risk factors 21). Eligible subjects to qualify must have will have GERD plus at least two additional risk factors for BE (white race, obesity defined as BMI \> 30, male gender, smoking history, family history).
Exclusion
- Patients with known coagulopathy (INR \> 1.5) will be excluded
- Patients with known esophageal varices will be excluded.
- Patients with significant dysphagia (unable to swallow solids) or odynophagia will be excluded
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT05210049
Start Date
March 1 2022
End Date
August 31 2024
Last Update
December 15 2022
Active Locations (1)
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1
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States, 44016