Recruiting

WATS3D

Sponsor:

CDx Diagnostics

Code:

NCT04312633

Conditions

Barrett Esophagus

Gastro Esophageal Reflux

Esophageal Dysplasia

Esophageal Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Barrett Esophagus

Gastro Esophageal Reflux

Esophageal Dysplasia

Esophageal Diseases

Study ID

NCT04312633

Start date

Apr 1, 2020

Status verified date

Mar, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

90000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Primary Outcome Measure: [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Karen Hoffman, M.D.

845-777-7000khoffman@cdxdiagnostics.com

William Cuddy

845-368-7452wcuddy@cdxdiagnostics.com

Locations

NYU Langone Ambulatory Care

Recruiting

Bethpage, New York, United States, 11714

Contacts

Matthew J McKinley, M.D.

516-758-8600Matthew.McKinley@nyulangone.org

More Information

Sponsor

CDx Diagnostics

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CDx Diagnostics on 2026-03-20.