Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter, Single-Arm Study of the Efficacy of EsoGuard(TM) on Samples Collected Using EsoCheck(TM) Versus Esophagogastroduodenoscopy for the Diagnosis of Barrett's Esophagus in an At-Risk Screening Population

Conditions
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Barrett Esophagus, Esophageal Adenocarcinoma, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia

Intervention / Treatment
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* Device: EsoGuard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men aged 50 years old and older ≥5 years either of GERD symptoms, GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control is achieved or not), or, any combination of treated and untreated periods, as long the cumulative total is at least 5 years 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 Oropharyngeal tumor History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure History of myocardial infarction or cerebrovascular accident within past 6 months History of esophageal motility disorder Currently implanted Linx device

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Multicenter, Single Arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EsoCheck vs. EGD with or without biopsies<br>All subjects will undergo both the EsoCheck (non-invasive esophageal cell sample collection) followed by EGD (with or without biopsies) | Device: EsoGuard<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%. | Cross-sectional point in time per subject through study completion which is up to approximately 5 weeks |