NCT04293458

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Lucid Diagnostics, Inc. · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Barrett Esophagus
• Esophageal Adenocarcinoma
• Barretts Esophagus With Dysplasia
• Barrett's Esophagus Without Dysplasia

Interventions

Type	Name	Description
DEVICE	EsoGuard	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)

Timeline

• Start date: 2020-02-28
• Primary completion: 2022-08-22
• Completion: 2022-08-22
• First posted: 2020-03-03
• Last updated: 2023-01-25

Locations

27 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated device study