Clinical trial · Interventional
Efficacy of EsoGuard Assay on Esophageal Surface Cells Collected With EsoCheck vs EGD for the Diagnosis of BE or EAC
A Multicenter Case-Control Study of the Efficacy of EsoGuard on Samples Collected Using EsoCheck, Versus Esophagogastroduodenoscopy, for the Diagnosis of Barrett's Esophagus With and Without Dysplasia, and for Esophageal Adenocarcinoma
NCT04295811CI-TRIAL-00063397ESOGUARDBE2active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The study will assess the performance of the combined system, i.e., the use of the EsoGuard assay (lab developed test) on cells collected using the EsoCheck (501k cleared device) to detect Barrett's Esophagus (BE), with or without dysplasia, and esophageal adenocarcinoma (EAC) as compared to Esophagogastroduodenoscopy (EGD) plus biopsies in both confirmed cases of BE/EAC and in controls (subjects without a prior diagnosis but undergoing screening for BE/EAC)
Conditions
Conditions (4)
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 | — |
| Barretts Esophagus With Dysplasia | — | UNRESOLVED | — |
| Barrett's Esophagus Without Dysplasia | — | UNRESOLVED | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EsoGuard (lab assay) | Device | — | UNRESOLVED |
| Esophagogastroduodenoscopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EsoCheck and EsoGuard vs. EGD with or without biopsies
- description
- 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
- interventionNames
- Device: EsoGuard (lab assay)
- Diagnostic Test: Esophagogastroduodenoscopy
Primary outcomes (1)
- measure
- Primary Efficacy
- timeFrame
- Per subject analysis through study completion which is up to approximately 5 weeks
- description
- The primary efficacy endpoint is the sensitivity of EsoGuard. The primary efficacy objectives of this study are to measure the sensitivities of EsoGuard-based diagnosis in 54 cases each of non-dysplastic Barrett's Esophagus (NDBE), low grade dysplasia (LGD), high grade dysplasia (HGD), and intramucosal adenocarcinoma (IMC) in order to assess EsoGuard's ability to detect disease across the entire continuum of disease progression.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: All Patients: 1. Men aged 50 years and above 2. ≥5 years either of * Gastroesophageal Reflux Disease (GERD) symptoms, * GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control is achieved or not), or * any combination of treated and untreated periods, as long the cumulative total is at least 5 years 3. No solid foods eaten for at least 2 hours prior to EsoCheck procedure 4. One or more of the following: * Caucasian race * Current or past history of cigarette smoking * Body mass index (BMI) of at least 30 kg/m2 * First-degree relative with Barrett's Esophagus (BE) or Esophageal Adenocarcinoma (EAC) Cases: 1. Previous diagnosis of non-dysplastic Barrett's Esophagus (NDBE), low grade dysplasia (LGD), high grade dysplasia (HGD), and/or intramucosal adenocarcinoma (IMC) 2. Diagnosis by esophagogastroduodenoscopy (EGD) (with exception of NDBE) was within 4 months prior to study enrollment 3. Indicated for surveillance EGD or for therapeutic EGD 4. Able to provide, by day of study EGD, the original glass slide(s) of biopsy specimens from most recent prior EGD Exclusion Criteria: 1. Inability to provide written informed consent 2. On anti-coagulant drug(s) that cannot be temporarily discontinued 3. Known history of esophageal varices or esophageal stricture 4. 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 5. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills 6. Oropharyngeal tumor 7. History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication procedure 8. History of myocardial infarction or cerebrovascular accident within past 6 months 9. Any known lesion which, in the opinion of the endoscopist, obstructs greater than 25% of the esophageal lumen 10. Prior participation in PR-0139/EG-CL-101 (Lucid BE Screening Study) 11. Prior EGD during which a therapeutic procedure such as, but not limited to, ablation, cryotherapy or endoscopic mucosal resection, was performed for the treatment of BE and/or EAC 12. History of esophageal motility disorder 13. Currently implanted Linx device
References
Publications (0)
Data not yet available
No reference posted for this study.