Tethered Capsule Endoscope in Screening Patients With Barrett Esophagus (NCT02729948) | Clinical Trial Compass
CompletedNot Applicable
Tethered Capsule Endoscope in Screening Patients With Barrett Esophagus
United States1 participantsStarted 2016-07-28
Plain-language summary
This pilot clinical trial studies how well tethered capsule endoscope works in screening patients with Barrett esophagus (BE), a condition where the lining of the esophagus has changed or has been replaced with abnormal cells that may lead to cancer also called esophageal cancer. In an attempt to prevent the progression from BE to esophageal cancer, patients undergo a standard procedure called esophagogastroduodenoscopy (EGD) where patients are sedated and the doctor uses an endoscope to examine the tissue in the esophagus. Tethered capsule endoscope is a tiny capsule with a laser scan inside and a very thin cord attached to it. Patients swallow the capsule and the thin cord keeps the capsule in specific area in the esophagus. After pictures of the lining of esophagus are taken, the capsule is removed using the thin cord. Tethered capsule endoscope may be able to identify tissue changes in patients with BE without the need for sedation or anesthesia, thus eliminating the associated risks and costs associated with EGD.
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:
* Ability and willingness to provide written informed consent
* Scheduled for endoscopic screening and/or evaluation of Barrett's esophagus
Exclusion Criteria:
* Previous history of a swallowing disorder, such as scleroderma, achalasia, esophageal stricture or esophageal diverticulum
* Symptoms of dysphagia
* Suspicion or known history of gastrointestinal obstruction
* History of prior surgery on the oropharynx, neck, esophagus, or stomach
* Current diagnosis of cancer, unstable cardiovascular disease, end-stage liver or kidney disease, or other major medical illness
* Currently taking anticoagulant medications or clopidogrel
* Major physical disability which would prevent subject from transferring from a chair to a bed and sitting in an upright position
* Inability to abstain from taking anything by mouth for at least 6 hours
* Currently pregnant
* Expected to undergo magnetic resonance imaging (MRI) within two weeks following the study procedure
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
Consistent image quality
Timeframe: At the conclusion of TCE exam (day 1)
2
Consistent usability defined as no significant change to the tolerance rating given by the patient by survey, and ease of use by the physician by survey, and time for completing the examination
Timeframe: At the conclusion of TCE exam (day 1)
3
Incidence of adverse events associated with TCE use