Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Barrett Esophagus
- Barrett's Esophagus Without Dysplasia
- Barrett's Esophagus With Dysplasia
- Esophageal Adenocarcinoma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Multicenter, Single ArmMasking: None (Open Label)Primary Purpose: Screening
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Only males
Description
This is a multicenter, single-arm study designed to assess the operating characteristics of the EsoGuard diagnostic assay performed on distal esophageal mucosal cells collected using the EsoCheck cell collection device, compared to the gold standard, for the screening of BE with and without dysplasi...
This is a multicenter, single-arm study designed to assess the operating characteristics of the EsoGuard diagnostic assay performed on distal esophageal mucosal cells collected using the EsoCheck cell collection device, compared to the gold standard, for the screening of BE with and without dysplasia and for esophageal adenocarcinoma (EAC), in patients at high risk for BE and for whom a screening EGD is indicated according to ACG-established criteria.
Tracking Information
- NCT #
- NCT04293458
- Collaborators
- Not Provided
- Investigators
- Study Director: Randy Brown, MS Lucid Diagnostics
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