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.
This is a multicenter, single-arm study designed to assess the operating characteristics of the EsoGuard diagnostic assay performed on distal esophageal mucosal cells collected using the EsoCheck cell collection device, compared to the gold standard, for the screening of BE with and without dysplasia and for esophageal adenocarcinoma (EAC), in patients at high risk for BE and for whom a screening EGD is indicated according to ACG-established criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
145
EsoGuard assay (LDT) will be used on cells collected using EsoCheck (510K cleared esophageal cell collection device) and compared to results of EGD plus biopsies (when taken)
Lucid Investigative Site
Primary Efficacy
The sensitivity and specificity of EsoGuard for the diagnosis of BE on samples collected using EsoCheck, wherein the definitive diagnosis of BE is made by concomitant EGD and biopsy.
Time frame: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks
Secondary Efficacy
Negative predictive value (NPV) and positive predictive value (PPV), calculated for the observed prevalence and over a range of prevalences from 1 to 15%.
Time frame: Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks
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