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

Primary Purpose

Barrett Esophagus, Esophageal Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EnteroTracker
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Barrett Esophagus

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enterotracker

Arm Description

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.

Outcomes

Primary Outcome Measures

Study Esophageal Mucosal Samples using Enterotracker Device
Capture esophageal mucosal samples in at least 50% of the test subjects using the EnteroTracker®.
Testing Tolerability via "Post-Procedure Tolerability Survey"
At least 50% of subjects describe the EnteroTracker® as "Satisfactory" from taking a "Post-Procedure Tolerability Survey".
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 5, 2022
Last Updated
January 20, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05706025
Brief Title
Pilot Study to Evaluate Utility of EnteroTracker® as a Minimally Invasive Sampling Method to Screen for Barrett's Esophagus and Esophageal Cancer
Acronym
Enterotracker
Official Title
Pilot Study to Evaluate Utility of EnteroTracker® as a Minimally Invasive Sampling Method to Screen for Barrett's Esophagus and Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus, Esophageal Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
The EnteroTracker® is a capsule device that includes an absorbent string.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enterotracker
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EnteroTracker
Intervention Description
The EnteroTracker® is a capsule device that includes an absorbent string.
Primary Outcome Measure Information:
Title
Study Esophageal Mucosal Samples using Enterotracker Device
Description
Capture esophageal mucosal samples in at least 50% of the test subjects using the EnteroTracker®.
Time Frame
2 years
Title
Testing Tolerability via "Post-Procedure Tolerability Survey"
Description
At least 50% of subjects describe the EnteroTracker® as "Satisfactory" from taking a "Post-Procedure Tolerability Survey".
Time Frame
2 years
Title
Testing difference in Biomarkers between Control and BE/EAC patients
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Studying DNA Collection using Enterotracker Device
Description
Capture at least 1 µg of DNA from the EnteroTracker® obtained mucosal samples in at least 50% of the test subjects.
Time Frame
2 years
Title
Testing Symptoms via Follow Up Adverse Event assessment call
Description
No more than 50% of subjects experienced more than one of the following side effects: nausea, choking, sore throat, vomiting, or chest pain.
Time Frame
2 years
Title
Testing difference in Multiple Biomarkers between Control and BE/EAC patients
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jack R O'Hara, BA
Phone
2489258736
Email
jack.ohara@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sachin Wani, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin Wani, MD
Phone
720-848-2746
Email
sachin.wani@cuanschutz.edu

12. IPD Sharing Statement

Learn more about this trial

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

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