WATS3D for the Detection of Esophageal Dysplasia
NCT03008980 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 160
Last updated 2021-11-04
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
- OTHER
-
Diagnostic Test
Sponsors & Collaborators
-
Rockford Gastroenterology Associates
collaborator OTHER -
Icahn School of Medicine at Mount Sinai
collaborator OTHER -
Temple University
collaborator OTHER -
University of Rochester
collaborator OTHER -
University of Kansas Medical Center
collaborator OTHER - collaborator OTHER
-
CDx Diagnostics
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-05-31
- Primary Completion
- 2015-01-31
- Completion
- 2018-12-31
Countries
- United States
Study Locations
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