NCT05706025Enrolling by invitation
Study to Evaluate EnteroTracker® as a Sampling Method to Screen for Barrett's Esophagus/Esophageal Cancer
Pilot Study to Evaluate Utility of EnteroTracker® as a Minimally Invasive Sampling Method to Screen for Barrett's Esophagus and Esophageal Cancer
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 5 Oct 2022
- Start date
- 31 May 2023
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05706025
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 31 May 2023 to the primary completion date, 1 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills within 3 months of EnteroTracker® procedure
- Known history of esophageal varices or esophageal stricture
- Oropharyngeal cancer
- History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication
- History of esophageal motility disorder
Other
- Inability to provide written informed consent
- Pregnant women
- Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EnteroTracker® procedure
- Currently implanted Linx device
Who the study is looking for
- 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
- 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
- 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
Age in the registry: 45 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.