WATS3D for Esophageal Conditions: A 5-Year Study

This study is creating a registry (a research database) to learn more about two ways of taking tissue samples from your esophagus (the tube that carries food to your stomach). These methods are using forceps and using a brush to collect small tissue samples. The study will look at how the brush biopsy results affect your doctor's decisions about your future care. Researchers also want to see if either the brush biopsy, the forceps biopsy, or both can predict who with heartburn might develop Barrett's esophagus (a condition that can lead to cancer) or who with Barrett's esophagus might develop precancer or cancer. You can join if you are 18 or older, having an upper endoscopy with both types of biopsies as part of your standard care, and can understand and sign the consent form. The study will follow participants for 5 years.

Study design
This is an observational study, meaning researchers will collect data without giving you a specific treatment. It plans to include 90,000 participants.
What's involved
You will undergo an upper endoscopy with forceps and brush biopsies as part of your standard medical care. Your biopsy results will be recorded over 5 years.
Compensation
Not stated in the trial record.
Follow-up
Your biopsy results will be recorded over 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04312633

Clinical Utility of WATS3D: A 5-Year Prospective Study

Recruiting
Not specifiedAges 18+Observational
CDx Diagnostics
~90,000 participants
Updated 2026-03-20 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome Measure:
Measured over 5 years
Barrett Esophagus
Gastro Esophageal Reflux
Esophageal Dysplasia
Esophageal Diseases
1 sites across 1 states
New York1
  • Matthew McKinley, M.D. · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.

Exclusion

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
  • Primary Outcome Measure:5 years

    Clinical Utility of WATS3D as determined by how many patients undergo increased surveillance, radiofrequency ablation and placement on PPIs.