Clinical trial · Interventional
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia
- 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)
This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of 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 |
|---|---|---|---|
| Cytosponge Procedure | Device | — | UNRESOLVED |
| Endoscopic Assessment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Known or Suspected Barrett's Esophagus (Case Arm)
- description
- Investigators will follow Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.c. After the sponge is retrieved, it will then be placed in a vial of cell preservative solution (PN DD-13631, Exact Sciences, Madison, WI) and shipped to the Exact Sciences laboratory for further processing and subsequent analysis.
- interventionNames
- Device: Cytosponge Procedure
- Diagnostic Test: Endoscopic Assessment
- type
- ACTIVE_COMPARATOR
- label
- No Known Barrett's Esophagus (Control Arm)
- description
- Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
- interventionNames
- Device: Cytosponge Procedure
- Diagnostic Test: Endoscopic Assessment
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with known or suspected Barrett's esophagus (BE) (cases) * Patients between the ages of 18-90. * Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record. * Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record. * Undergoing clinically indicated endoscopy. * Subjects without known history of BE (controls) * Undergoing clinically indicated diagnostic endoscopy Exclusion Criteria: * For subjects with or without known evidence of BE (on history or review of medical records) * Pregnant or lactating females. * Patients who are unable to consent. * Patients with current history of uninvestigated dysphagia. * History of eosinophilic esophagitis, achalasia. * Patients on oral anticoagulation including Coumadin, Warfarin. * Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the Cytosponge procedure. * Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the Cytosponge procedure. * Patients with history of known esophageal or gastric varices or cirrhosis. * Patients with history of surgical esophageal resection for esophageal carcinoma. * Patients with congenital or acquired bleeding diatheses. * Patients with a history of esophageal squamous dysplasia. * Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment. * Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.
References
Publications (0)
Data not yet available