drugset / Trial / NCT02029937
High Resolution Microendoscopy for the Detection of Esophageal Squamous Cell Neoplasia
Phase 2
Unknown
1300 enrolled
Anandasabapathy, Sharmila, M.D.
Baylor College of Medicine · collabWilliam Marsh Rice University · collab
RandomizedParallel-groupOpen-labelOther
Summary
The overall objective of this multicenter trial is to determine whether the use of a low-cost, high-resolution microendoscope during diagnostic upper endoscopy can improve the efficiency and accuracy of endoscopic screening for esophageal squamous cell neoplasia. This is a multicenter clinical trial of a novel technology, a miniaturized, lower cost (\< $3, 500) microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This high-resolution microendoscope (HRME) was developed by our collaborators at RICE University and provides \>1000X magnified images of the esophageal mucosa.
Timeline
- Start
- 2014-01
- Primary completion
- 2021-12
- Completion
- 2021-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Proflavine | Diagnostic / imaging agent | 0.01 % | Topical |
| Subject | Proflavine | Diagnostic / imaging agent | 5 ml | Topical |
| Subject | Proflavine | Diagnostic / imaging agent | 10 ml | Topical |