Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for men and women over 45 with a history of Barrett's Esophagus or esophageal cancer, who can swallow a small capsule. It's not for pregnant individuals, those with certain esophageal conditions like varices or strictures, past major esophageal surgery (except simple fundoplication), recent swallowing difficulties, implanted Linx devices, or if they've had specific treatments for Barrett's/esophageal cancer.Treatment Details
The study tests the EnteroTracker®, a minimally invasive device to screen for Barrett’s Esophagus and Esophageal Cancer by capturing biomarkers. The goal is to see if it could replace endoscopic biopsies and be used comfortably at home.
1Treatment groups
Experimental Treatment
Group I: EnterotrackerExperimental Treatment1 Intervention
The EnteroTracker® is a capsule device that includes an absorbent string. The trailing end of the string is taped to the cheek and the capsule is swallowed with 8-12 ounces of water. The capsule dislodges the string as it travels to the proximal small intestine. The capsule continues through the remainder of the GI tract, leaving a string in the esophagus, stomach, and duodenum. Following a 60-minute dwell time, the string is removed via the subjects' mouth and processed for analysis. Subjects will be coached to ease any potential anxieties and answer any questions. A preparatory video can be used for education if desired.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of ColoradoAurora, CO
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor