Clinical Utility of WATS3D: A 5-Year Prospective Study

Launched by CDX DIAGNOSTICS · Mar 16, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods for taking small tissue samples from the esophagus, which is the tube that carries food from your mouth to your stomach. The study aims to gather information on these methods—one uses small forceps to take biopsies, and the other uses a brush. The goal is to better understand how these techniques work, especially for patients with conditions like Barrett Esophagus or those experiencing heartburn and other esophageal issues.

To participate in this study, you need to be at least 18 years old and able to read and understand the consent form. You might be eligible if you have symptoms like heartburn and are scheduled for a procedure called an EGD (which checks the esophagus), or if you already have Barrett Esophagus and are undergoing regular check-ups. The study will last for five years, and during this time, participants will have both types of tissue samples taken. If you have any serious health issues or are pregnant, you may not be able to join. Overall, this study is an opportunity to help improve the understanding of esophageal diseases and how to diagnose them better.

Gender

ALL

Eligibility criteria

• 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