NCT06071845

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. Measure Deoxyribonucleic acid (DNA) yield from esophageal cytology samples collected with the Cytosponge device. II. Evaluate the methylated DNA markers (MDM) levels and accuracy of the Oncoguard Esophagus test (OGE test) for the detection of methylated DNA markers in Cytosponge collected esophageal cytology samples. SECONDARY OBJECTIVES: I. Assess the tolerability of the Cytosponge device using a tolerability questionnaire II. Evaluate presence of any trauma to the esophagus from the passage of the Cytosponge device using the endoscopic injury score. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients with known or suspected Barrett's Esophagus undergo a biopsy and sample collection with the cytosponge followed by standard of care endoscopy and complete surveys while on study. ARM II: Patients without known or suspected Barrett's Esophagus undergo a biopsy and sample collection with the cytosponge followed by standard of care endoscopy and complete surveys while on study.

Conditions

• Barrett Esophagus
• Barretts Esophagus With Dysplasia
• Barrett's Esophagus Without Dysplasia
• Esophageal Adenocarcinoma

Interventions

Type	Name	Description
DEVICE	Cytosponge Procedure	Investigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.
DIAGNOSTIC_TEST	Endoscopic Assessment	Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.

Timeline

• Start date: 2023-10-16
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-10-10
• Last updated: 2025-12-16

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study