Detection of Barrett s Esophagus in Patients Without GERD Symptoms (NCT04880044) | Clinical Trial Compass
CompletedNot Applicable
Detection of Barrett s Esophagus in Patients Without GERD Symptoms
United States132 participantsStarted 2022-01-05
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 e…
What they're measuring
1
Positive Predictive Value (PPV) of EC/EG in a Non-GERD Population That Has Three or More Non-GERD Risk Factors for BE.
Timeframe: Up to 2 months
2
Proportion of Participants Negative Via EC/EG Who Subsequently Are Proven Negative Via EGD