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Behavioural Intervention
EnteroTracker Screening for Esophageal Cancer and Barrett's Esophagus (Enterotracker Trial)
Phase 1
Waitlist Available
Led By Sachin Wani, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Enterotracker Trial Summary
This trial will test a device to measure biomarkers in order to screen for Barrett's Esophagus and Esophageal Adenocarcinoma. It may also be used at home.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include discomfort from swallowing the device similar to ingesting a large pill. Since this is an observational tool rather than medication, traditional drug side effects may not apply.
Enterotracker Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Study Esophageal Mucosal Samples using Enterotracker Device
Testing Tolerability via "Post-Procedure Tolerability Survey"
Testing difference in Biomarkers between Control and BE/EAC patients
Secondary outcome measures
Studying DNA Collection using Enterotracker Device
Testing Symptoms via Follow Up Adverse Event assessment call
Testing difference in Multiple Biomarkers between Control and BE/EAC patients
Enterotracker Trial Design
1Treatment groups
Experimental Treatment
Group I: EnterotrackerExperimental Treatment1 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.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,734 Previous Clinical Trials
2,148,823 Total Patients Enrolled
Sachin Wani, MDPrincipal InvestigatorUniversity of Colorado, Denver
8 Previous Clinical Trials
9,379 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on my esophagus or stomach, but it was not a complex fundoplication.I have cancer in the back of my throat.I am 45 years old or older.I can swallow a pill the size of Tylenol.I have a history of swollen veins or narrowing in my esophagus.I have been diagnosed with a type of Barrett's Esophagus or esophageal cancer.I have a history of swallowing disorders.I have had trouble or pain swallowing, including pills, in the last 3 months.I had an endoscopy in the last 3 months or can arrive early for one to swallow an EnteroTracker®.I have had GERD for 5 years, treated or not.I've had a procedure like ablation or cryotherapy for Barrett's esophagus or esophageal cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Enterotracker
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can you speak to the potential risks of using Enterotracker?
"Enterotracker has a score of 1, as this clinical trial is in its initial phase and only limited safety data is available."
Answered by AI
Are there vacancies available to enroll in this research endeavor?
"Clinicaltrials.gov states that this clinical trial, first posted on March 1st 2023 and last updated on January 20th of the same year, is not presently recruiting participants. Nevertheless, there are currently 397 additional medical studies actively looking for patients."
Answered by AI
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