RecruitingNCT04312633

Clinical Utility of WATS3D: A 5-Year Prospective Study

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

Sponsor

CDx Diagnostics

Enrollment

90,000 participants

Start Date

Apr 1, 2020

Study Type

OBSERVATIONAL

Conditions

Barrett Esophagus Esophageal Diseases Gastro Esophageal Reflux Esophageal Dysplasia

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria3

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