Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE (NCT04293458) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE
United States145 participantsStarted 2020-02-28
Plain-language summary
The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay on cells collected using the EsoCheck 510(k) cleared device, to detect Barrett's Esophagus, with and without dysplasia, and/or Esophageal Adenocarcinoma, in individuals deemed to be at high risk for these conditions (i.e., screening) per ACG guidelines.
Who can participate
Age range50 Years
SexMALE
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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
✓. Men aged 50 years old and older
✓. ≥5 years either of
✓. No solid foods eaten for at least 2 hours prior to EsoCheck procedure
✓. One or more of the following risk factors:
✓. Caucasian race
✓. Current or past history of cigarette smoking
✓. BMI of at least 30 kg/m2
✓. First-degree relative with BE or EAC
Exclusion criteria
✕. History of prior EGD procedure
✕. Inability to provide written informed consent
✕. On anti-coagulant drug(s) that cannot be temporarily discontinued
✕. Known history of esophageal varices or esophageal stricture
✕. Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, 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
What they're measuring
1
Primary Efficacy
Timeframe: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks