Status:
COMPLETED
The Evaluation of Patients With Esophageal and Foregut Disorders With WATS (Wide Area Transepithelial Sample With 3-Dimensional Computer-Assisted Analysis) vs. 4-Quadrant Forceps Biopsy
Lead Sponsor:
CDx Diagnostics
Collaborating Sponsors:
Foundation for Surgical Innovation and Education
Conditions:
GERD
Barrett Esophagus
Eligibility:
All Genders
18+ years
Brief Summary
Patients scheduled to undergo routine upper endoscopy for foregut or esophageal symptoms or undergoing surveillance for Barrett's esophagus with no dysplasia or low-grade dysplasia are candidates for ...
Detailed Description
Patients scheduled to undergo routine upper endoscopy for foregut or esophageal symptoms will be enrolled. Patients undergoing surveillance for Barrett's esophagus with no dysplasia or low-grade dyspl...
Eligibility Criteria
Inclusion
- Both males and females at least 18 years of age undergoing routine upper endoscopy to evaluate symptoms of esophageal or foregut disorders (reflux disease, BE, esophageal strictures, swallowing disorders, dyspepsia, hiatal hernias, motility issues, gastric issues).
- Institutional Review Board (IRB)-approved consent must be signed by patients prior to participating in this study.
Exclusion
- Patients who do not undergo either FB or WATS biopsy
- Patients with inadequate WATS or FB specimens
- Known history of high-grade dysplasia or adenocarcinoma
- Prior history of endoscopic resection or ablation for Barrett's with high-grade dysplasia or adenocarcinoma
Key Trial Info
Start Date :
October 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
1032 Patients enrolled
Trial Details
Trial ID
NCT03859557
Start Date
October 1 2017
End Date
December 31 2018
Last Update
March 1 2019
Active Locations (1)
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1
Providence Portland Medical Center
Portland, Oregon, United States, 97213