Clinical Utility of WATS3D: A 5-Year Prospective Study

Recruiting now

Conditions studied: Barrett Esophagus, Gastro Esophageal Reflux, Esophageal Dysplasia, Esophageal Diseases

In brief

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.

Key facts

Study ID

NCT04312633

Run by

CDx Diagnostics

People needed

90000

Starts

2020-04-01

Expected to finish

2027-11-01

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to read, comprehend and complete the IRB-approved consent form
• Aged 18 or older
• Meet one of the following:
• Patients with heartburn or regurgitation undergoing a screening EGD, who undergo WATS3D sampling and forceps biopsies for suspicion of BE, or
• Patients with known BE with or without dysplasia undergoing a surveillance EGD with WATS3D biopsies and forceps biopsies, or
• Patients who have undergone endoscopic eradication (i.e. radiofrequency ablation or cryoablation) who are undergoing surveillance EGD following the establishment of complete eradication of intestinal metaplasia (CEIM)
• Only patients who undergo both forceps biopsies and WATS3D of the esophagus will be included.

You may not qualify if…

• Pregnancy at time of endoscopy
• Unresolved drug or alcohol dependency that will limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions or follow-up guidelines
• Medical condition that will likely prohibit completion of a 5 year study

Where it is running

• NYU Langone Ambulatory Care — Bethpage, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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