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

NCT05706025 | Enrolling By Invitation DMC FDA Device

• 2 other identifiers: 22-0320.ccBIOE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett Esophagus; Esophageal Cancer

Outcome Measures

Primary Outcomes (3)

• Study Esophageal Mucosal Samples using Enterotracker Device

  Capture esophageal mucosal samples in at least 50% of the test subjects using the EnteroTracker®.

  2 years

• Testing Tolerability via "Post-Procedure Tolerability Survey"

  At least 50% of subjects describe the EnteroTracker® as "Satisfactory" from taking a "Post-Procedure Tolerability Survey".

  2 years

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

  At least one biomarker differentiated between BE/EAC patients and control subjects in at least 50% of test subjects. Samples will be analyzed for various biomarkers including proteins, DNA, RNA and/or methylation of DNA.

  2 years

Secondary Outcomes (3)

• Studying DNA Collection using Enterotracker Device

  2 years

• Testing Symptoms via Follow Up Adverse Event assessment call

  2 years

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

  2 years

Study Arms (1)

Enterotracker

EXPERIMENTAL

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.

Device: EnteroTracker

Interventions

EnteroTracker DEVICE

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

Enterotracker

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision to sign and date the consent form.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Be a male or female aged 45 years or older.
• Previous diagnosis of indefinite Barrett's Esophagus (IND), non-dysplastic (ND), low grade dysplasia (LGD), high grade dysplasia (HGD), and/or esophageal adenocarcinoma (EAC)
• Able to swallow a Tylenol sized capsule
• Diagnostic endoscopy performed within past 3 months or able to arrive early to endoscopy for EnteroTracker® to be swallowed before endoscopy
• \. 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 \[47\].
• \. Apparently healthy or ≥5 years of:
• Gastroesophageal Reflux Disease (GERD) symptoms, or
• GERD treated with proton pump inhibitor (PPI) therapy (whether symptom control was achieved or not), or
• Any combination of treated and untreated periods if the cumulative total is at least 5 years

You may not qualify if:

• History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills within 3 months of EnteroTracker® procedure
• Inability to provide written informed consent
• Pregnant women
• 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
• Known history of esophageal varices or esophageal stricture
• Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EnteroTracker® procedure
• Oropharyngeal cancer
• History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication
• History of esophageal motility disorder
• Currently implanted Linx device

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Study Officials

• Sachin Wani, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: January 31, 2023
• Study Start: May 31, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)