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Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE — ESOGUARDBE1  

Barrett Esophagus Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04293458
Study type Interventional
Source PAVmed Inc.
Contact
Status Completed
Phase N/A
Start date February 28, 2020
Completion date August 22, 2022
View Details
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