NCT03015389

Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Tissue Analysis (WATS3D) For the Detection of High Grade Esophageal Dysplasia and Adenocarcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 170 (actual)
• Sponsor: CDx Diagnostics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, prospective, randomized study which will enroll patients undergoing endoscopic surveillance due to a history of histologically confirmed dysplasia. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study.

Conditions

• Barrett Esophagus
• Esophageal Dysplasia
• Esophageal Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Diagnostic Test	WATS3D brush biopsy

Timeline

• Start date: 2017-09-27
• Primary completion: 2019-02-18
• Completion: 2019-02-18
• First posted: 2017-01-10
• Last updated: 2020-07-23

Locations

1 site across 1 country: Belgium