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

Recruiting in Palo Alto (17 mi)

Sachin Wani, MD | Profiles | School of ...

Overseen bySachin Wani, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

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.

Inclusion Criteria

I am 45 years old or older.

Stated willingness to comply with all study procedures and be available for the duration of the study

I can swallow a pill the size of Tylenol.

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Exclusion Criteria

I have had surgery on my esophagus or stomach, but it was not a complex fundoplication.

Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EnteroTracker® procedure

I have cancer in the back of my throat.

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Treatment Details

Interventions

EnteroTracker (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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.