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NCT03859557 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by CDx Diagnostics.
- Completed
- Registry status
- 1,032
- Enrollment target
NCT03859557: Completed study, sponsored by CDx Diagnostics.
NCT03859557 is a clinical trial that has completed, run by CDx Diagnostics. The registered enrollment target is 1,032 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03859557 has completed, sponsored by CDx Diagnostics.
- COMPLETED
- Registry status
- 1,032 participants
- Enrollment target
Study 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 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.
Primary Outcome
Intestinal metaplasia is a premalignant change in the normal epithelium lining the esophagus and gastroesophageal junction. It is evaluated on tissue samples from these areas by a pathologist under a microscope, who then determines if intestinal metaplasia is present or not. All specimens retrieved by upper endoscopy, whether by standard biopsy or by WATS, will be examined by a pathologist. The pathology reports will be reviewed and the frequency that intestinal metaplasia is found by standard b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,032 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2018-12-31 |
What the finished NCT03859557 record still lists
NCT03859557 is an observational study that tracks outcomes without assigning an intervention. Its 1,032 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT03859557 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03859557 about?
NCT03859557 is a clinical study titled "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". 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 p...
What is the current status of trial NCT03859557?
This trial is currently completed. The enrollment target is 1,032 participants. The study started on 2017-10-01. Estimated completion is 2018-12-31.
Who is sponsoring clinical trial NCT03859557?
This trial is sponsored by CDx Diagnostics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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