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
Completed
Conditions studied: GERD, Barrett Esophagus, Low Grade Esophageal Glandular Dysplasia, Esophageal Diseases
In brief
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 participation, but patients with known high-grade dysplasia or adenocarcinoma or with a history of prior endoscopic resection or ablation for these conditions are not candidates for participation. At endoscopy, all patients will be initially assessed for the presence of an endoscopic suspicious lesion using white light and if appropriate narrow band imaging or similar enhanced imaging techniques. All suspicious lesions undergo targeted biopsy first, and then either 4-Quadrant Random Forceps Biopsy or WATS biopsies of the GEJ and if present the columnar-lined esophagus based on the assigned randomization away from the area of targeted biopsies. A biopsy will be obtained from the antrum in each patient to assess for H. pylori infection and the presence of intestinal metaplasia.
Key facts
- Study ID
- NCT03859557
- Run by
- CDx Diagnostics
- People needed
- 1032
- Starts
- 2017-10-01
- Expected to finish
- 2018-12-31
- Last updated by the study team
- 2019-03-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Providence Portland Medical Center — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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