NCT05706025

Study to Evaluate EnteroTracker® as a Sampling Method to Screen for Barrett's Esophagus/Esophageal Cancer

Pilot Study to Evaluate Utility of EnteroTracker® as a Minimally Invasive Sampling Method to Screen for Barrett's Esophagus and Esophageal Cancer

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether the EnteroTracker can obtain biomarkers that have been studied to be significant in screening BE and EAC. The current standard of care is endoscopic biopsy where the pathologist will visualize the tissue under a microscope to interpret diagnosis. Another goal of this study is to understand tolerance of the procedure so it might be used in an at-home setting.

Detailed description

This study seeks to determine the ability of a minimally invasive capsule-string device, the EnteroTracker®, to capture biomarkers associated with Barrett's Esophagus (BE) and Esophageal Adenocarcinoma (EAC). Identification of biomarkers in samples will support development of this simple-to-use, scalable, method for early screening of EAC, a cancer that accounts for the majority of esophageal cancers in the United States. In this study, the investigators plan to capture esophageal luminal content using the EnteroTracker® from patients with confirmed BE and/or EAC (test group) and healthy adults (control group). Samples will then be analyzed for series of biomarkers associated with BE and/or EAC. The investigators will test the hypothesis that the EnteroTracker® is able to capture biomarkers of interest in subjects with BE and EAC compared to healthy controls. To address this hypothesis, the investigators propose a pilot study with the following two specific aims. Evaluate the ability and tolerability of the EnteroTracker® to capture esophageal mucosal samples in adults with BE and/or EAC as well as controls and determine the ability of the EnteroTracker®-obtained BE/EAC biomarkers to distinguish between BE and/or EAC from control subjects.

Conditions

• Barrett Esophagus
• Esophageal Cancer

Interventions

Type	Name	Description
DEVICE	EnteroTracker	The EnteroTracker® is a capsule device that includes an absorbent string.

Timeline

• Start date: 2023-05-31
• Primary completion: 2028-03-01
• Completion: 2029-03-01
• First posted: 2023-01-31
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study