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

Status: Recruiting
Location: See location...
Study Type: Observational [Patient Registry]
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: No
View:

• English speaking

• Able to read, comprehend, and complete the consent form

• Aged 18 to 80, and,

• 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 therapy(including, but not limited to endoscopic mucosal resection, endoscopic submucosal dissection, radiofrequency ablation and/orcryoablation/spray cryotherapy)who are undergoing surveillance EGD following the establishment of complete eradication of intestinal metaplasia (CEIM) with accompanying WATS3D sampling and forceps biopsies.

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
Recruiting
Chapel Hill
Contact Information
Primary
Karen Hoffman, M.D.
khoffman@cdxdiagnostics.com
8453687463
Time Frame
Start Date: April 2016
Estimated Completion Date: April 2026
Participants
Target number of participants: 10000
Sponsors
Leads: CDx Diagnostics
Collaborators: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov