Actively Recruiting
CDx Study 906: Clinical Utility of WATS3D Using Forceps and Brush Esophageal Biopsies in Barrett's Esophagus A 5-Year Prospective Registry
Led by CDx Diagnostics · Updated on 2026-03-20
90000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to gather and analyze data about two methods used to take small tissue samples from the esophagus: biopsies taken with forceps and brush biopsies. The study focuses on patients with heartburn or Barrett's esophagus, a condition that can lead to cancer. The goal is to understand how these biopsy methods may help doctors predict the development of precancerous changes or cancer over five years. Participants will undergo standard clinical care involving an upper endoscopy, during which both forceps and brush biopsies of the esophagus will be taken. These biopsy results will be collected and recorded in a research database for five years to observe their impact on medical decisions and patient outcomes. The study is observational and does not involve additional treatments beyond usual care. During the study, participants' biopsy results will be monitored and recorded over a five-year period. Researchers will assess how the biopsy findings influence care decisions and whether either biopsy method can predict disease progression. Participants will continue their routine medical visits and evaluations as part of this long-term observation, with all study-related data collected to support research goals.
CONDITIONS
Brief Title
Clinical Utility of WATS3D: A 5-Year Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read, comprehend, and complete the IRB-approved consent form
- Aged 18 or older
- Patients with heartburn or regurgitation undergoing a screening upper endoscopy with both WATS3D sampling and forceps biopsies for suspicion of Barrett's esophagus
- Patients with known Barrett's esophagus with or without dysplasia undergoing surveillance upper endoscopy with both WATS3D and forceps biopsies
- Patients who have undergone endoscopic eradication and are undergoing surveillance upper endoscopy following complete eradication of intestinal metaplasia
- Only patients who undergo both forceps biopsies and WATS3D of the esophagus will be included
You will not qualify if you...
- Pregnancy at time of endoscopy
- Unresolved drug or alcohol dependency limiting ability to comprehend or follow study instructions
- Medical conditions likely to prevent completion of the 5-year study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo upper endoscopy with both forceps and brush biopsies of the esophagus as part of their standard clinical care.
1 visit (in-person)
Duration - Up to 5 years
Participants are observed over 5 years to record biopsy results and assess outcomes related to Barrett's esophagus and its progression.
Follow-up visits during routine clinical care
Trial Site Locations
Total: 1 location
1
NYU Langone Ambulatory Care
Bethpage, New York, United States, 11714
Actively Recruiting
Research Team
K
Karen Hoffman, M.D.
W
William Cuddy
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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