The study will assess the performance of the combined system, i.e., the use of the
EsoGuard assay on cells collected using the EsoCheck 510(k) cleared device, to detect
Barrett's Esophagus, with and without dysplasia, and/or Esophageal Adenocarcinoma, in
individuals deemed to be at high risk for these conditions (i.e., screening) per ACG
guidelines.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04293458.
Locations matching your search criteria
United States
Colorado
Aurora
UCHealth University of Colorado HospitalStatus: Active
Contact: Sandra Boimbo
Phone: 303-724-8892
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.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationLucid Diagnostics, Inc.
