drugset / Trial / NCT02018367

Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma

NCT02018367

RandomizedParallel-groupOpen-labelOther

Summary

The overall goal of the study is to determine whether imaging with the low-cost High Resolution Microendoscope(HRME) will increase the efficiency and yield of the current standard of endoscopic surveillance of Barrett's esophagus. We believe the HRME will provide an in-vivo "optical biopsy" that will be comparable to gold standard histopathology and allow the endoscopist to make a more informed decision about whether to obtain a biopsy or even perform endoscopic therapy (i.e. endoscopic mucosal resection, EMR).

Timeline

Start
2012-09
Primary completion
2021-12
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Proflavine Diagnostic / imaging agent 0.01 % Topical

Indications