NCT02988934

The WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) U.S. Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3,173 (actual)
• Sponsor: CDx Diagnostics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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. By recording the results of all of your biopsies over many 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. The data from your biopsies will be used to determine the best way to diagnose esophageal disease. 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 your standard clinical care, and you are between the ages of 18 and 80.

Conditions

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

Timeline

• Start date: 2016-04-01
• Primary completion: 2023-02-07
• Completion: 2023-02-07
• First posted: 2016-12-12
• Last updated: 2023-02-08

Locations

1 site across 1 country: United States