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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the EnteroTracker, a capsule with an absorbent string, can screen for esophageal cancer and Barrett's Esophagus by collecting key biomarkers. The trial also seeks to assess the comfort and ease of using this device, potentially even at home. It targets individuals aged 45 and older who have Barrett's Esophagus, esophageal cancer, or have experienced GERD (acid reflux) symptoms for at least five years. Participants must be able to swallow a capsule similar in size to a Tylenol pill. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance early detection methods for esophageal conditions.

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 prior data suggests that the EnteroTracker is safe for screening esophageal conditions?

Research has shown that EnteroTracker has been used for conditions like eosinophilic esophagitis, a long-term illness causing swelling in the esophagus, suggesting it might be safe. However, specific safety information for its current use in detecting esophageal cancer and Barrett's esophagus remains limited.

The trial is in an early stage, so while safety information is still being collected, the treatment's safety for everyone is not yet fully confirmed. Researchers carefully monitor safety and side effects, and participants receive thorough information about possible risks. Prospective participants should ask questions and discuss any concerns with the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The EnteroTracker is unique because it offers a non-invasive way to screen for esophageal cancer and Barrett's esophagus. Unlike traditional methods like endoscopy, which require sedation and a hospital visit, the EnteroTracker involves swallowing a capsule with an absorbent string that collects samples as it passes through the digestive tract. Researchers are excited because this method could make screening much more accessible and comfortable, potentially leading to earlier detection and treatment of these conditions.

What evidence suggests that the EnteroTracker is effective for screening esophageal cancer and Barrett's esophagus?

Research shows that the EnteroTracker, used by participants in this trial, is a promising tool for detecting esophageal cancer and Barrett's Esophagus. Studies have found that it successfully collects samples from the esophagus, stomach, and small intestine. These samples are tested for biomarkers, which can help detect these conditions early. Unlike traditional methods such as endoscopic biopsy, the EnteroTracker is less invasive and may be more comfortable for patients. Early results suggest it could even be used at home, making the screening process easier and more accessible. ^{1 5 6 7 8}

Who Is on the Research Team?

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.

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 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?

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+

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.

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05706025?cond=Barrett%27s%20esophagus%20OR%20Barrett%27s%20oesophagus%20OR%20gastroesophageal%20reflux%20disease%20OR%20GERD%20OR%20GORD%20OR%20reflux%20oesophagitis%20OR%20reflux%20esophagitis%20OR%20oesophageal%20adenocarcinoma%20OR%20esophageal%20adenocarcinoma&start=2017-08-31_2024-06-04&aggFilters=ages:adult%20older,studyType:int&page=3&rank=211

Study to Evaluate EnteroTracker® as a Sampling Method ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-02388

Evaluating the EnteroTracker (Registered Trademark) as a ... This clinical trial evaluates the effectiveness and tolerability of a minimally-invasive sampling device called EnteroTracker to obtain mucosal samples from ...

3. fox40.com fox40.com/business/press-releases/ein-presswire/622725937/clinical-trial-underway-to-evaluate-the-enterotracker-for-home-based-screening-of-be-and-esophageal-cancer

Clinical Trial Underway to Evaluate the EnteroTracker® for ... This study will provide further insight into the EnteroTracker's potential for home-based use. If successful, this would be a significant ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10922282/

Advances in Screening for Barrett's Esophagus and ... Several studies have shown that uTNE for BE screening, is both safe and well-tolerated and offers similar diagnostic yield as EGD. ... A ...

5. withpower.com withpower.com/clinical-trials/for-barretts-esophagus

Top Barrett's Esophagus Clinical Trials | Power The 5-year survival rate is as low as 18% for patients who get esophageal adenocarcinoma, but the rate may be improved if the cancer is caught in its early ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05706025

NCT05706025 | Study to Evaluate EnteroTracker® as a ... This study seeks to determine the ability of a minimally invasive capsule-string device, the EnteroTracker®, to capture biomarkers associated with Barrett's ...

7. news.cuanschutz.edu news.cuanschutz.edu/cancer-center/enterotracker-shandas-esophageal-cancer

Can a String Replace Endoscopies for Esophageal Cancer ... The EnteroTracker originally was developed for use in detecting and monitoring eosinophilic esophagitis (EoE), a chronic condition caused by an ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12182032/

Systematic mapping of registered interventional studies ... Obesity and esophageal cancer: GERD, Barrett's esophagus, and molecular carcinogenic pathways. Expert Rev Gastroenterol Hepatol. 2020;14:425 ...