Clinical Utility of WATS3D: A 5-Year Prospective Study

Barrett Esophagus Clinical Trial

Official title:

CDx Study 906: The Clinical Utility of WATS3D (Wide Area Transepithelial Sampling With Computer-Assisted 3-Dimensional Analysis): A 5- Year Prospective Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04312633
• Other study ID #: CDx 906
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: November 2023
• Source: CDx Diagnostics
• Contact: Karen Hoffman, M.D.
• Phone: 845-777-7000
• Email: khoffman[@]cdxdiagnostics.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

This study will look at the impact of the brush biopsy results on your doctor's decisions about your future care and treatment.

In addition , by recording the results of all your biopsies over 5 years, it may be possible to find out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and which patients with Barrett's esophagus develop precancer and cancer.

You are being asked to participate in the study because you are receiving an upper endoscopy (a procedure where a tube with a light and camera are inserted in your mouth and down your throat) with forceps and brush biopsies of your esophagus as part of you standard clinical care, and you are at least 18 years old.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90000
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Diseases
• Esophageal Dysplasia
• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Locations

Country	Name	City	State
United States	NYU Langone Ambulatory Care	Bethpage	New York

Sponsors (1)

Lead Sponsor	Collaborator
CDx Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary Outcome Measure:	Incremental detection yield due to WATS sampling as number of patients who have Barrett's Esophagus and Esophageal Dysplasia determined by WATS and missed by forceps biopsies.	5 years