EnteroTracker Screening for Esophageal Cancer and Barrett's Esophagus (Enterotracker Trial)

N/A

Waitlist Available

Led By Sachin Wani, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a device to measure biomarkers in order to screen for Barrett's Esophagus and Esophageal Adenocarcinoma. It may also be used at home.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include discomfort from swallowing the device similar to ingesting a large pill. Since this is an observational tool rather than medication, traditional drug side effects may not apply.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Study Esophageal Mucosal Samples using Enterotracker Device

Testing Tolerability via "Post-Procedure Tolerability Survey"

Testing difference in Biomarkers between Control and BE/EAC patients

Secondary study objectives

Studying DNA Collection using Enterotracker Device

Testing Symptoms via Follow Up Adverse Event assessment call

Testing difference in Multiple Biomarkers between Control and BE/EAC patients

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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