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Diagnostic Test

Non-Endoscopic Esophageal Sampling for Barrett's Esophagus and Esophageal Cancer

N/A
Recruiting
Led By Katarina B Greer, MD/MS
Research Sponsored by Cleveland VA Medical Research and Education Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Patients with known coagulopathy (INR > 1.5) will be excluded Patients with known esophageal varices will be excluded. Patients with significant dysphagia (unable to swallow solids) or odynophagia will be excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 2.5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new method for detecting Barrett's esophagus and esophageal cancer in primary care patients. The new method, called Esocheck/Esoguard, is non-endoscopic, meaning it does not require a scope be inserted down the throat. The trial will compare the new method's effectiveness to that of standard endoscopic screening.

Who is the study for?
This trial is for Veterans aged 40-85 with GERD symptoms, no prior upper endoscopies, and at least two additional risk factors for Barrett's Esophagus such as obesity or a smoking history. They must be able to consent and not have coagulopathy, esophageal varices, or significant swallowing pain.
What is being tested?
The study tests Esocheck/Esoguard, non-endoscopic tools for detecting Barrett's Esophagus and esophageal cancer in primary care. It aims to see if these methods can improve the accuracy of endoscopy predictions and increase detection rates.
What are the potential side effects?
While specific side effects are not detailed here, non-endoscopic procedures like Esocheck/Esoguard typically involve less discomfort than traditional scopes with minimal risks such as throat irritation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have blood clotting issues, esophageal varices, or severe swallowing pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 2.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sensitivity and Specificity of Esocheck/Esoguard in a Veteran population
Secondary study objectives
Cost of two screening strategies
Number/percentage of screened patients with diagnosis of Barrett's esophagus and/or esophageal adenocarcinoma

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: Patients undergoing routine screening via upper endoscopy (EGD)Experimental Treatment1 Intervention
All enrolled patients will complete upper endoscopy for screening for Barrett's esophagus and esophageal adenocarcinoma.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
906 Previous Clinical Trials
333,245 Total Patients Enrolled
Cleveland VA Medical Research and Education FoundationLead Sponsor
Katarina B Greer, MD/MSPrincipal InvestigatorLouis Stokes Cleveland VA Medical Center

Media Library

Esocheck/Esoguard (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05210049 — N/A
Acid Reflux Clinical Trial 2023: Esocheck/Esoguard Highlights & Side Effects. Trial Name: NCT05210049 — N/A
Esocheck/Esoguard (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05210049 — N/A
Acid Reflux Research Study Groups: Patients undergoing routine screening via upper endoscopy (EGD)
~34 spots leftby Nov 2025
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