Clinical trial · Interventional
Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms
NCT06687603CI-TRIAL-00118815recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to develop a method to detect Barrett's esophagus in individuals with a new office based diagnostic test. Barrett's esophagus is a condition in which the flat pink lining of the swallowing tube that connects the mouth to the stomach (the esophagus) becomes damaged by acid reflux. The main question it aims to answer is: Can this approach demonstrate efficacy for screening of Barrett's esophagus? Participants will: * Participate in a questionnaire. * Undergo a capsule balloon test, called EsoCheck. * Have their EsoCheck sample sent to the laboratory for an EsoGuard test, which is used to detect Barrett's esophagus. * Participants will undergo upper endoscopy as part of standard of care.
Conditions
Conditions (3)
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 Esophagus | — | UNRESOLVED | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastroesophageal Reflux | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EsoCheck | Device | — | UNRESOLVED |
| EsoGuard | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EsoCheck + EsoGuard
- description
- Participants will undergo an EsoCheck test. The sample produced by the EsoCheck will be sent to LucidDx where the EsoGuard assay will be performed.
- interventionNames
- Device: EsoCheck
- Diagnostic Test: EsoGuard
Primary outcomes (3)
- measure
- Positive predictive value for Barret's Esophagus in EsoCheck/EsoGuard positive participants
- timeFrame
- Up to 5 years
- description
- The primary goal of this study is to develop a non-endoscopic screening test for the non-GERD population that provides a PPV \>20%, i.e. at least 2-fold greater than the 10% PPV of society recommended EGD screening of chronic GERD patients with any additional risk factors.
- measure
- Barrett's Esophagus prevalence in EsoCheck/EsoGuard test negative subjects from a high-risk GERD negative population
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: Patients undergoing screening colonoscopy are an accessible cohort for BE screening and are also a reasonable representation of the general population. Permission will be obtained from colonoscopy physicians for researchers to contact and recruit patients for this study. Patients without GERD, who are at risk for BE, and who have not had a prior EGD, will be recruited prior to or at the time of scheduled colonoscopy.(9) Those eligible will be: * Adults who have not had prior EGD within past ten years, and are able to provide informed consent, and who have: * No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have: * No significant dysphagia or odynophagia; but who do have: * Absence of GERD (absence of weekly heartburn or regurgitation, not on medications for GERD), and are: * Adults \> age 50, who also have two or more added risk factors for BE from the set of: central obesity (waist size \> 35 inches for women and \> 40 inches for men), current smoker or smoking history \> 10 pack years, white race, male sex, confirmed history of BE/EAC in at least two family members, with one a first degree relative. While BE is most highly prevalent in white males, a black female over age 50 with obesity and a positive smoking history would also be at increased BE risk and would equally meet eligibility criteria. * Subjects must have the ability to understand and the willingness to sign a written informed consent document. * Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * History of prior EGD procedure in past ten years * 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 INR \> 1.5 * Known history of esophageal varices or esophageal stricture * Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, 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 of uncomplicated surgical fundoplication procedure
References
Publications (0)
Data not yet available
No reference posted for this study.