MedTrace Logo

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

NCT04293458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2023-01-25

No results posted yet for this study

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.

Conditions

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

Interventions

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)

Sponsors & Collaborators

  • Lucid Diagnostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michelle McDermott · Lucid Diagnostics

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-28
Primary Completion
2022-08-22
Completion
2022-08-22
FDA Device
Yes

Countries

  • United States
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04293458 on ClinicalTrials.gov