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Clinical Trials in the USA / NCT04312633
Recruiting Observational

Clinical Utility of WATS3D: A 5-Year Prospective Study

NCT04312633 · tracked via the Priya Life Science USA tracker
Sponsor
CDx Diagnostics
Phase
Observational
Started
2020-04-01
Last updated
2026-03-20

Condition(s) studied

Barrett EsophagusGastro Esophageal RefluxEsophageal DysplasiaEsophageal Diseases

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Primary Outcome Measure: — 5 years
    Clinical Utility of WATS3D as determined by how many patients undergo increased surveillance, radiofrequency ablation and placement on PPIs.

Trial sites (1)

FacilityCityRegionStatus
NYU Langone Ambulatory Care Bethpage New York Recruiting

Other trials for the same condition

Efficacy of EsoGuard Assay on Esophageal Surface Cells Collected With EsoCheck vs EGD for the Diagnosis of BE or EAC Active, not recruiting
Lucid Registry Study Recruiting
Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System Active, not recruiting
Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples Recruiting
Safety and Feasibility Study of the CELLSPAN Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04312633 on ClinicalTrials.gov ↗ ← All trials in the USA