60 Participants Needed

EnteroTracker Screening for Esophageal Cancer and Barrett's Esophagus

(Enterotracker Trial)

JR
Overseen ByJack R O'Hara, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
Must be taking: Proton pump inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.678910

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.69111213

Who Is on the Research Team?

Sachin Wani, MD | Profiles | School of ...

Sachin Wani, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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.
See 4 more

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.
See 7 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: EnterotrackerExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Published Research Related to This Trial

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

Citations

Biomarkers in Barrett's Esophagus: Role in Diagnosis, Risk Stratification, and Prediction of Response to Therapy. [2022]
How to get the most out of costly Barrett's oesophagus surveillance. [2019]
Screening for Barrett's Esophagus. [2022]
Screening for Barrett's esophagus and esophageal adenocarcinoma: rationale, recent progress, challenges, and future directions. [2021]
Who Deserves Endoscopic Screening for Esophageal Neoplasia? [2018]
Adverse Event Fatalities Related to GI Endoscopy. [2022]
Comparison of a Voluntary Safety Reporting System to a Global Trigger Tool for Identifying Adverse Events in an Oncology Population. [2023]
Patient-reported adverse events after colonoscopy in Norway. [2018]
Novel classification for adverse events in GI endoscopy: the AGREE classification. [2023]
Crizotinib-induced esophageal ulceration: a novel adverse event of crizotinib. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Point-Counterpoint: Screening and Surveillance for Barrett's Esophagus, Is It Worthwhile? [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Novel Screening Tests for Barrett's Esophagus. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Does screening for Barrett's esophagus and adenocarcinoma of the esophagus prolong survival? [2005]
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