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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

No Placebo-Only Group

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
Esophageal cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ per subject through study completion which is up to approximately 5 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Efficacy

Secondary study objectives

Secondary Efficacy

Other study objectives

Safety outcome of EsoCheck Device (510k cleared, non-invasive, esophageal cell collection device) on all patients who undergo the device procedure.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1240

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