NCT03008980

WATS3D for the Detection of Esophageal Dysplasia

Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Analysis (WATS) for the Detection of Esophageal Dysplasia: A Prospective, Randomized, Tandem Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: CDx Diagnostics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients will be recruited from participating institutions prior to planned routine care EGD with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who are potentially eligible for the study will be approached regarding the study. If interested, participants will be consented and proceed with routine care EGD. The study coordinator or other research personnel will document information from the routine care endoscopy as part of this research study. Follow-up information collected will include WATS3D cytology and forceps biopsy pathology results from any routine care endoscopy performed during the course of participation in the study, any surgeries received and related to their condition, and any other care received as part of their condition. WATS3D samples will be sent to CDx Diagnostics for analysis.

Conditions

• Barrett Esophagus
• Esophageal Dysplasia
• Esophagus Adenocarcinoma

Interventions

Type	Name	Description
OTHER	Diagnostic Test

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-01-01
• Completion: 2018-12-01
• First posted: 2017-01-04
• Last updated: 2021-11-04

Locations

1 site across 1 country: United States