Clinical Utility of WATS3D: A 5-Year Prospective Study

NCT04312633 | Recruiting

• 1 other identifier: CDx 906
• Study Type: observational
• Target: 90,000
• Locations: 1 country
• Sites: 1

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

Gastro Esophageal Reflux; Esophageal Dysplasia; Esophageal Diseases; Barrett Esophagus

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure:

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

  5 years

Secondary Outcomes (1)

• Secondary Outcome Measure:

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* 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)

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

Sponsors & Collaborators

• CDx Diagnostics: lead

Study Sites (1)

NYU Langone Ambulatory Care

Bethpage, New York, 11714, United States

RECRUITING

MeSH Terms

Conditions

Barrett Esophagus; Gastroesophageal Reflux; Esophageal Diseases

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Study Officials

• Matthew McKinley, M.D.

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Hoffman, M.D.

CONTACT

845-777-7000; khoffman@cdxdiagnostics.com

William Cuddy

CONTACT

845-368-7452; wcuddy@cdxdiagnostics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 18, 2020
• Study Start: April 1, 2020
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (1)