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Efficacy of EsoGuard Assay on Esophageal Surface Cells Collected With EsoCheck vs EGD for the Diagnosis of BE or EAC

NCT04295811 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 470

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 (lab developed test) on cells collected using the EsoCheck (501k cleared device) to detect Barrett's Esophagus (BE), with or without dysplasia, and esophageal adenocarcinoma (EAC) as compared to Esophagogastroduodenoscopy (EGD) plus biopsies in both confirmed cases of BE/EAC and in controls (subjects without a prior diagnosis but undergoing screening for BE/EAC)

Conditions

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

Interventions

DEVICE

EsoGuard (lab assay)

EsoGuard assay (LDT) will be used on cells collected using the EsoCheck (510K cleared esophageal cell collection device)

DIAGNOSTIC_TEST

Esophagogastroduodenoscopy

Planned EGD to diagnose and/or treat disorders of esophagus, stomach, and small intestine. When abnormal tissues are noted, biopsies of the tissue are taken through the scope to diagnose tissue abnormalities.

Sponsors & Collaborators

  • Lucid Diagnostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michelle McDermott · Lucid Diagnostics, Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States
  • Netherlands

Study Locations

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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 NCT04295811 on ClinicalTrials.gov