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Barrett EsophagusNCT05706025

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

A study testing EnteroTracker in people with Barrett Esophagus and Esophageal Cancer, run by University of Colorado, Denver at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for
Barrett Esophagus, Esophageal Cancer
What is being tested?
EnteroTracker
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
31 May 2023to 1 Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • Oropharyngeal cancer
  • History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication
  • History of esophageal motility disorder
  • Currently implanted Linx device

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • University of Colorado

    Aurora, Colorado, 80045

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
EnteroTracker
Medical subject headings
Barrett Esophagus, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnteroTrackerDevice

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

Study groups in NCT05706025
Study groupRoleWhat they receive
EnterotrackerExperimentalThe 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.
Receives: Device: EnteroTracker

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study Esophageal Mucosal Samples using Enterotracker Device

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

    Measured: 2 years

  2. Testing Tolerability via "Post-Procedure Tolerability Survey"

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

    Measured: 2 years

  3. 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.

    Measured: 2 years

Secondary outcomes (3)

  1. 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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2023
  2. Study start31 May 2023
  3. Primary completion1 Mar 2028 (estimated)
  4. Study completion1 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
The EnteroTracker® is a capsule device that includes an absorbent string.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05706025
Sponsor's protocol ID
22-0320.cc
Other IDs
BIOE
Status last verified
Apr 2025
First submitted
5 Oct 2022
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing EnteroTracker in people with Barrett Esophagus and Esophageal Cancer, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Esophageal Mucosal Samples using Enterotracker Device (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05706025.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.

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