RecruitingNCT04312633

Clinical Utility of WATS3D: A 5-Year Prospective Study

CDx Study 906: The Clinical Utility of WATS3D (Wide Area Transepithelial Sampling With Computer-Assisted 3-Dimensional Analysis): A 5- Year Prospective Registry


Sponsor

CDx Diagnostics

Enrollment

90,000 participants

Start Date

Apr 1, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is the tube that carries food and liquid from your mouth to your stomach). The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples) from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This long-term study is testing whether a new tissue sampling technique called WATS3D (a brush that collects cells from a wide area of the esophagus) can detect Barrett's esophagus or early cancer more accurately than standard forceps biopsies when used together during routine endoscopy. **You may be eligible if...** - You are at least 18 years old - You are having an upper endoscopy (EGD) for heartburn, acid reflux, or to check for Barrett's esophagus - You have known Barrett's esophagus (with or without dysplasia) undergoing surveillance - You have already had treatment to remove Barrett's esophagus and are being monitored - You will undergo both the standard biopsy and the WATS3D brush biopsy during the procedure **You may NOT be eligible if...** - You are pregnant at the time of the procedure - You have unresolved drug or alcohol dependency that prevents you from giving informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

NYU Langone Ambulatory Care

Bethpage, New York, United States

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NCT04312633


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