WATS3D for the Detection of Esophageal Dysplasia (NCT03008980) | Clinical Trial Compass
CompletedNot Applicable
WATS3D for the Detection of Esophageal Dysplasia
United States160 participantsStarted 2014-05
Plain-language summary
Patients will be recruited from participating institutions prior to planned routine care EGD with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who are potentially eligible for the study will be approached regarding the study. If interested, participants will be consented and proceed with routine care EGD. The study coordinator or other research personnel will document information from the routine care endoscopy as part of this research study. Follow-up information collected will include WATS3D cytology and forceps biopsy pathology results from any routine care endoscopy performed during the course of participation in the study, any surgeries received and related to their condition, and any other care received as part of their condition. WATS3D samples will be sent to CDx Diagnostics for analysis.
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 esophagus (with or without dysplasia of either indefinite, low grade or high-grade)
* Willingness to undergo both WATS and 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 undergo both forceps biopsies and WATS of the esophagus will be included in this study
Exclusion criteria:
* Coagulopathy with an international normalized ratio above 2.0;
* Thrombocytopenia with platelet counts below 50,000
* History of prior esophageal ablation therapies, esophageal or gastric surgery
* Unresolved drug or alcohol dependency
* Pregnancy or planned pregnancy during the study period
* Patients found to have a BE length less than 1 cm or greater than 10 cm
* Patients with any visible lesions greater than 10 mm
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
Outcomes of patients undergoing WATS sampling. Specifically incremental yield for Barrett's Esophagus and Esophageal Dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings.