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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 is a clinical trial that has completed, run by CDx Diagnostics. The registered enrollment target is 1,032 participants.
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,032 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2018-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03859557
The ClinicalTrials.gov registry entry for NCT03859557 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,032 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CDx Diagnostics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT03859557 reports 0 study locations.
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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