Study to Evaluate EnteroTracker® as a Sampling Method to Screen for Barrett's Esophagus/Esophageal Cancer
NCT05706025 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-04-06
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.
Conditions
- Barrett Esophagus
- Esophageal Cancer
Interventions
- DEVICE
-
EnteroTracker
The EnteroTracker® is a capsule device that includes an absorbent string.
Sponsors & Collaborators
-
University of Colorado, Denver
lead OTHER
Principal Investigators
-
Sachin Wani, MD · University of Colorado, Denver
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-05-31
- Primary Completion
- 2028-03-01
- Completion
- 2029-03-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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