N/A N=132 Screening

Detection of Barrett s Esophagus in Patients Without GERD Symptoms

Barrett's Esophagus

Bottom Line

View on ClinicalTrials.gov: NCT04880044 ↗

Enrolled (actual)

132

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Positive Predictive Value (PPV) of EC/EG in a Non-GERD Population That Has Three or More Non-GERD Risk Factors for BE. — 33 Percentage of screened participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EsoCheck/EsoGuard (EC/EG) (Diagnostic_test); Esophago-gastro-duodenoscopy (EGD) (Diagnostic_test)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Case Comprehensive Cancer Center
Primary completion: Feb 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Positive Predictive Value (PPV) of EC/EG in a Non-GERD Population That Has Three or More Non-GERD Risk Factors for BE.	33	—
PRIMARY Proportion of Participants Negative Via EC/EG Who Subsequently Are Proven Negative Via EGD	100	—

Summary

The purpose of this study is to develop a method to detect Barrett's esophagus (BE) in individuals with a new office-based diagnostic test.

Eligibility Criteria

Inclusion Criteria

No known coagulopathy, no known esophageal varices.
No significant dysphagia or odynophagia
Absence of chronic GERD, defined as five or more years of heartburn or regurgitation with symptoms at least once a week when not on medications for GERD symptoms.
Subjects to qualify must meet criterion 3, be over age 50, and have two additional risk factors for BE (white race, central obesity defined as waist size >35 inches for women and >40 inches for men, male gender, current smoker or smoking history >10 pack years, confirmed family history in at least two members with one being a first degree relative).

Exclusion Criteria

History of prior EGD procedure
Inability to provide written informed consent
History of weekly of more frequent heartburn or regurgitation for five or more years
On anti-coagulant drug(s)that cannot be temporarily discontinued or coagulopathy with international normalized ratio (INR) > 1.5
Known history of esophageal varices or esophageal stricture
Any contraindication, as deemed inInvestigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGDprocedure,and/or having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and/or esophageal ulceration
History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills
Oropharyngeal tumor
History of esophageal or gastric surgery, with exception on uncomplicated surgical fundoplication procedure
History of myocardial infarction or cerebrovascular accident within past 6 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04880044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.