Clinical Utility of WATS3D: A 5-Year Prospective Study

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

Clinical Utility of WATS3D: A 5-Year Prospective Study

Condition
Barrett Esophagus
Intervention / Treatment

-

Contacts and Locations

Bethpage

NYU Langone Ambulatory Care, Bethpage, New York, United States, 11714

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CDx Diagnostics,

Matthew McKinley, M.D., PRINCIPAL_INVESTIGATOR, NYU Grossman School of Medicine

Study Record Dates

2027-11-01