Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy (NCT02994693) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
United States100 participantsStarted 2016-12
Plain-language summary
The goal of this research is to determine the natural history of Barrett's esophagus (BE) using tethered capsule endomicroscopy (TCE) in participants undergoing surveillance endoscopy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants with known BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,
* Participants over the age of 18
* Participants who are capable of giving informed consent
* Participants who had or will have a standard of care EGD within 9 to 15 months
* Participants must have no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.
Exclusion Criteria:
* Participants with prior endoscopic ablation or resection treatment of BE
* Participants with esophageal fistula and/or esophageal strictures with a luminal stricture diameter that is smaller than the diameter of the capsule
* Participants with the inability to swallow capsules.
* Pregnancy, according to participant information
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Longitudinal assessment of the Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Timeframe: Approximate 25 minutes visit (10 min image acquisition)