drugset / Trial / NCT02018367
Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma
Phase 2
Unknown
100 enrolled
Anandasabapathy, Sharmila, M.D.
Baylor College of Medicine · collabWilliam Marsh Rice University · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Proflavine | Diagnostic / imaging agent | 0.01 % | Topical |