Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional … (NCT03015389) | Clinical Trial Compass
CompletedNot Applicable
Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Tissue Analysis (WATS3D) For the Detection of High Grade Esophageal Dysplasia and Adenocarcinoma
Belgium170 participantsStarted 2017-09-27
Plain-language summary
This is a multi-center, prospective, randomized study which will enroll patients undergoing endoscopic surveillance due to a history of histologically confirmed dysplasia. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study.
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
. Patients age: ≥ 18 years
. Patients should have a history of Barrett's associated esophageal dysplasia (either low or high-grade) confirmed on histology
. Willingness to undergo both WATS3D and random forceps biopsies while undergoing conventional EGD with sedation
. Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
. Only patients who no visible mucosal abnormalities at the time that they undergo both random forceps biopsies and WATS3D testing of the esophagus will be included in this study
Exclusion criteria
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
Detection rate of Barrett's associated high grade esophageal dysplasia and esophageal adenocarcinoma (HGD/EAC) using WATS3D and random 4 quadrant forceps biopsies taken at 2 cm intervals.
. Coagulopathy with INR \> 2.0, thrombocytopenia with platelet counts \< 50,000
. The subject is pregnant or planning a pregnancy during the study period
. History of esophageal or gastric surgery other than Endoscopic Mucosal Resection (EMR)
. Patients who have undergone endoscopic ablative therapies
. Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
. Study patients with inadequate WATS3D specimens will not undergo a repeat brush biopsy test and will be excluded from the study
. BE length \< 1 cm or \> 10 cm
. Patients within six weeks of receiving targeted forceps biopsies and/or EMR