NCT04880044

Detection of Barrett s Esophagus in Patients Without GERD Symptoms

Detection of Barrett s Esophagus in Patients Without Gastroesophageal Reflux Disease (GERD) Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study will investigate whether using EsoCheck/EsoGuard(EC/EG) can detect BE in individuals at risk for BE who are currently not being detected and are not undergoing routine esophago-gastro-duodenoscopy (EGD) BE can only be diagnosed by performing upper endoscopy. Up to 500 adults who have risk factors for BE but do not have chronic heartburn or regurgitation will be enrolled in this study. This will include the EsoCheck/EsoGuard determination along with the upper endoscopy for qualifying EsoGuard negative subjects

Conditions

• Barrett's Esophagus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	EsoCheck/EsoGuard (EC/EG)	EC is a swallowed capsule on a tethered catheter that obtains a touch sample of the distal esophagus. The obtained sample is placed in a buffer and sent to a diagnostics lab for testing of methylated markers from extracted DNA. EG is a methylated DNA test . A positive EG is associated with Barrett's esophagus at all its stages.
DIAGNOSTIC_TEST	Esophago-gastro-duodenoscopy (EGD)	SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected.

Timeline

• Start date: 2022-01-05
• Primary completion: 2025-02-25
• Completion: 2025-02-25
• First posted: 2021-05-10
• Last updated: 2026-03-10
• Results posted: 2026-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study