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EsoCheck + EsoGuard for Barrett's Esophagus and Esophageal Adenocarcinoma (ESOGUARDBE2 Trial)

N/A
Recruiting
Research Sponsored by Lucid Diagnostics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up per subject through study completion which is up to approximately 5 weeks
Awards & highlights

Summary

This trial uses the EsoGuard test to detect esophageal diseases by analyzing cells collected with the EsoCheck device. It targets patients with Barrett's Esophagus and esophageal adenocarcinoma, as well as those undergoing screening. The test works by looking for specific DNA changes in the cells.

Eligible Conditions
  • Esophageal Cancer
  • Barrett's Esophagus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~per subject through study completion which is up to approximately 5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and per subject through study completion which is up to approximately 5 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy
Secondary outcome measures
Secondary Efficacy
Other outcome measures
Safety outcome of EsoCheck Device (510k cleared, non-invasive, esophageal cell collection device) on all patients who undergo the device procedure.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EsoCheck and EsoGuard vs. EGD with or without biopsiesExperimental Treatment2 Interventions
All subjects will undergo both the EsoGuard lab assay run on distal esophageal cells collected with EsoCheck (non-invasive esophageal cell sample collection) device followed by Esophagogastroduodenoscopy (EGD) with or without biopsies
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esophagogastroduodenoscopy
2017
Completed Phase 3
~980

Find a Location

Who is running the clinical trial?

Lucid Diagnostics, Inc.Lead Sponsor
5 Previous Clinical Trials
1,257 Total Patients Enrolled
Randy B, MSStudy DirectorLucid Diagnostics, Inc.
Michelle McDermottStudy DirectorLucid Diagnostics, Inc.
1 Previous Clinical Trials
145 Total Patients Enrolled

Media Library

EsoCheck Clinical Trial Eligibility Overview. Trial Name: NCT04295811 — N/A
~90 spots leftby Sep 2025
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