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

NCT ID: NCT05706025

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2029-03-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Enterotracker

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.

Group Type: EXPERIMENTAL

EnteroTracker

Intervention Type: DEVICE

The EnteroTracker® is a capsule device that includes an absorbent string.

Interventions

EnteroTracker

The EnteroTracker® is a capsule device that includes an absorbent string.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Provision to sign and date the consent form.

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

3. Be a male or female aged 45 years or older.

1. Previous diagnosis of indefinite Barrett's Esophagus (IND), non-dysplastic (ND), low grade dysplasia (LGD), high grade dysplasia (HGD), and/or esophageal adenocarcinoma (EAC)

2. Able to swallow a Tylenol sized capsule

3. Diagnostic endoscopy performed within past 3 months or able to arrive early to endoscopy for EnteroTracker® to be swallowed before endoscopy

1. The majority of BE and EAC patients are age 50 years and older. Fewer than 15% of the cases are found in people younger than age 55. However current literature has suggested that there has been an increase in cases among 45-65 years old [47].

6. Apparently healthy or ≥5 years of:

1. Gastroesophageal Reflux Disease (GERD) symptoms, or

2. GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control was achieved or not), or

3. Any combination of treated and untreated periods if the cumulative total is at least 5 years

Exclusion Criteria

1. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills within 3 months of EnteroTracker® procedure

2. Inability to provide written informed consent

3. Pregnant women

4. Prior EGD during which a therapeutic procedure such as, but not limited to, ablation, cryotherapy, or endoscopic mucosal resection, was performed for the treatment of BE and/or EAC

5. Known history of esophageal varices or esophageal stricture

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

7. Oropharyngeal cancer

8. History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication

9. History of esophageal motility disorder

10. Currently implanted Linx device

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sachin Wani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

BIOE

Identifier Type: OTHER

Identifier Source: secondary_id

22-0320.cc

Identifier Type: -

Identifier Source: org_study_id