EnteroTracker Screening for Esophageal Cancer and Barrett's Esophagus

(Enterotracker Trial)

Overseen By Jack R O'Hara, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: Proton pump inhibitors

Disqualifiers: Dysphagia, Pregnancy, Esophageal varices, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking medication for GERD, such as proton pump inhibitors, you may continue as the study includes participants with GERD treated with these medications.

What data supports the effectiveness of the treatment EnteroTracker for screening esophageal cancer and Barrett's Esophagus?

Recent advances in noninvasive tools for screening Barrett's esophagus, which is a precursor to esophageal cancer, have shown promise in improving early detection. These tools, along with risk assessment and biomarker panels, may help identify high-risk individuals more effectively, potentially leading to better outcomes. ^{1 2 3 4 5}

Is EnteroTracker safe for humans?

The research articles provided do not contain specific safety data about EnteroTracker or its use for esophageal cancer and Barrett's Esophagus. Therefore, no relevant safety information is available from these sources. ^{6 7 8 9 10}

How is the EnteroTracker treatment different from other treatments for esophageal cancer and Barrett's esophagus?

EnteroTracker is unique because it is a noninvasive tool designed for screening Barrett's esophagus and esophageal cancer, which may allow for early detection and better outcomes compared to traditional methods that often involve more invasive procedures like endoscopy. ^{3 4 11 12 13}

Research Team

Sachin Wani, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for men and women over 45 with a history of Barrett's Esophagus or esophageal cancer, who can swallow a small capsule. It's not for pregnant individuals, those with certain esophageal conditions like varices or strictures, past major esophageal surgery (except simple fundoplication), recent swallowing difficulties, implanted Linx devices, or if they've had specific treatments for Barrett's/esophageal cancer.

Inclusion Criteria

I am 45 years old or older.

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

I can swallow a pill the size of Tylenol.

Exclusion Criteria

I have had surgery on my esophagus or stomach, but it was not a complex fundoplication.

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

I have cancer in the back of my throat.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the EnteroTracker® device to capture esophageal mucosal samples for biomarker analysis

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after using the EnteroTracker® device

2 years

Follow-up calls for adverse event assessment

Treatment Details

Interventions

• EnteroTracker

Trial Overview The study tests the EnteroTracker®, a minimally invasive device to screen for Barrett’s Esophagus and Esophageal Cancer by capturing biomarkers. The goal is to see if it could replace endoscopic biopsies and be used comfortably at home.

Participant Groups

Group I: Enterotracker Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

The modified Global Trigger Tool (GTT) detected significantly more adverse events (AEs) in oncology patients (0.90 AEs per patient) compared to the voluntary safety reporting (VSR) system (0.24 AEs per patient), highlighting the GTT's greater efficacy in identifying medication-related AEs.

Over half of the AEs identified by the GTT caused harm to patients, with a notable portion being preventable, indicating a critical need for improved detection methods in oncology to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a Voluntary Safety Reporting System to a Global Trigger Tool for Identifying Adverse Events in an Oncology Population. Samal, L., Khasnabish, S., Foskett, C., et al.[2023]

The AGREE classification system for adverse events in gastrointestinal (GI) endoscopy was validated and showed an 80% agreement in severity perception among endoscopists, nurses, and patients, indicating its reliability.

The AGREE classification correlated significantly with the established ASGE classification, and was deemed simple, reproducible, and useful by 96% of experts, suggesting it can enhance the standardization and quality assurance of AE reporting in GI endoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel classification for adverse events in GI endoscopy: the AGREE classification. Nass, KJ., Zwager, LW., van der Vlugt, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Biomarkers in Barrett's Esophagus: Role in Diagnosis, Risk Stratification, and Prediction of Response to Therapy. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

How to get the most out of costly Barrett's oesophagus surveillance. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Screening for Barrett's Esophagus. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Screening for Barrett's esophagus and esophageal adenocarcinoma: rationale, recent progress, challenges, and future directions. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Who Deserves Endoscopic Screening for Esophageal Neoplasia? [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse Event Fatalities Related to GI Endoscopy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of a Voluntary Safety Reporting System to a Global Trigger Tool for Identifying Adverse Events in an Oncology Population. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Patient-reported adverse events after colonoscopy in Norway. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Novel classification for adverse events in GI endoscopy: the AGREE classification. [2023]

10. Ireland pubmed.ncbi.nlm.nih.gov

Crizotinib-induced esophageal ulceration: a novel adverse event of crizotinib. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Point-Counterpoint: Screening and Surveillance for Barrett's Esophagus, Is It Worthwhile? [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Novel Screening Tests for Barrett's Esophagus. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Does screening for Barrett's esophagus and adenocarcinoma of the esophagus prolong survival? [2005]