Clinical trial · Interventional
Detection of Barrett s Esophagus in Patients Without GERD Symptoms
Detection of Barrett s Esophagus in Patients Without Gastroesophageal Reflux Disease (GERD) Symptoms
NCT04880044CI-TRIAL-00105124completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EsoCheck/EsoGuard (EC/EG) | Diagnostic Test | — | UNRESOLVED |
| Esophago-gastro-duodenoscopy (EGD) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EC/EG & EGD
- description
- Participants will complete a study questionnaire about reflux symptoms. Performance of an EsoCheck (EC) procedure; the EC sample will subsequently be tested with the EsoGuard (EG) assay If EG assay results come back positive, participant is requested to complete standard of care (SOC) upper endoscopy (tissue samples collected) If EG assay results come back negative, selected participants (100 volunteers) will also undergo a research EGD if they consent
- interventionNames
- Diagnostic Test: EsoCheck/EsoGuard (EC/EG)
- Diagnostic Test: Esophago-gastro-duodenoscopy (EGD)
Primary outcomes (2)
- measure
- Positive Predictive Value (PPV) of EC/EG in a Non-GERD Population That Has Three or More Non-GERD Risk Factors for BE.
- timeFrame
- Up to 2 months
- description
- PPV of EC/EG in a non-GERD population that has three or more non-GERD risk factors for BE. Participants who are at risk will be offered EC/EG. Those who are positive will undergo subsequent EGD PPV = (EC/EG positive \& EGD positive) / ((EC/EG positive \& EGD positive) + (EC/EG positive \& EGD negative))
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDChak A, Keerthy K, Wang GM, Brock W, Bednarchik B, Guptha R, Verma S, Moinova H, Tatsuoka C, Dumot J, Thomas S, Willis JE, Markowitz S. Nonendoscopic Detection of Barrett's Esophagus on Patients Without Gastroesophageal Reflux Disease Symptoms. Am J Gastroenterol. 2026 Jan 1;121(1):258-261. doi: 10.14309/ajg.0000000000003669. Epub 2025 Aug 1. PMID 40748349