- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05706025
Pilot Study to Evaluate Utility of EnteroTracker® as a Minimally Invasive Sampling Method to Screen for Barrett's Esophagus and Esophageal Cancer (Enterotracker)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Jack R O'Hara, BA
- Phone Number: 2489258736
- Email: jack.ohara@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado
-
Contact:
- Sachin Wani, MD
- Phone Number: 720-848-2746
- Email: sachin.wani@cuanschutz.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
- Oropharyngeal cancer
- History of esophageal or gastric surgery, with exception of uncomplicated surgical fundoplication
- History of esophageal motility disorder
- Currently implanted Linx device
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Enterotracker
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.
|
The EnteroTracker® is a capsule device that includes an absorbent string.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study Esophageal Mucosal Samples using Enterotracker Device
Time Frame: 2 years
|
Capture esophageal mucosal samples in at least 50% of the test subjects using the EnteroTracker®.
|
2 years
|
Testing Tolerability via "Post-Procedure Tolerability Survey"
Time Frame: 2 years
|
At least 50% of subjects describe the EnteroTracker® as "Satisfactory" from taking a "Post-Procedure Tolerability Survey".
|
2 years
|
Testing difference in Biomarkers between Control and BE/EAC patients
Time Frame: 2 years
|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Studying DNA Collection using Enterotracker Device
Time Frame: 2 years
|
Capture at least 1 µg of DNA from the EnteroTracker® obtained mucosal samples in at least 50% of the test subjects.
|
2 years
|
Testing Symptoms via Follow Up Adverse Event assessment call
Time Frame: 2 years
|
No more than 50% of subjects experienced more than one of the following side effects: nausea, choking, sore throat, vomiting, or chest pain.
|
2 years
|
Testing difference in Multiple Biomarkers between Control and BE/EAC patients
Time Frame: 2 years
|
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.
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-0320
- BIOE (OTHER: University of Colorado)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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