drugset / Trial / NCT01384240

Evaluation of a Low-Cost High Resolution Microendoscope for the Detection of Lower Gastrointestinal Neoplasia

NCT01384240

Phase 0 Terminated 183 enrolled Anandasabapathy, Sharmila, M.D.
NaSingle-groupOpen-labelScreening

Summary

The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and neoplastic areas. This is a pilot study of a novel technology, a miniaturized microscope device which can be used during standard endoscopy to image the gastrointestinal epithelium. Theoretically, by visualizing superficial mucosal changes at a high-resolution and magnification, the investigators will be able to obtain optical images that can be used to guide endoscopic biopsy and polypectomy. This may foster the selective targeting of dysplasia/neoplasia, thereby improving diagnostic accuracy.

Timeline

Start
2010-04
Primary completion
2013-07
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Background Proflavine Diagnostic / imaging agent 3 ml