Pilot Study to Evaluate Utility of EnteroTracker® as a Minimally Invasive Sampling Method to Screen for Barrett's Esophagus and Esophageal Cancer

Study Overview
=================
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.

Official Title
-----------------
Pilot Study to Evaluate Utility of EnteroTracker® as a Minimally Invasive Sampling Method to Screen for Barrett's Esophagus and Esophageal Cancer

Conditions
-----------------
Barrett Esophagus, Esophageal Cancer

Intervention / Treatment
-----------------
* Device: EnteroTracker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Fit in the below listed inclusion criteria Inclusion Criteria for Test Population (BE and EAC subjects): 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 Inclusion Criteria for Control Population (otherwise healthy adults with no evidence of BE or EAC or other esophageal cancer but with GERD) 4. Able to swallow a Tylenol sized capsule 5. 45 years of age or older 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: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: The EnteroTracker® is a capsule device that includes an absorbent string.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enterotracker<br>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<br>* The EnteroTracker® is a capsule device that includes an absorbent string.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Studying DNA Collection using Enterotracker Device | Capture at least 1 µg of DNA from the EnteroTracker® obtained mucosal samples in at least 50% of the test subjects. | 2 years | 
| Testing Symptoms via Follow Up Adverse Event assessment call | No more than 50% of subjects experienced more than one of the following side effects: nausea, choking, sore throat, vomiting, or chest pain. | 2 years | 
| Testing difference in Multiple Biomarkers between Control and BE/EAC patients | More than 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 |