drugset / Trial / NCT03220711

Study of Performance of Confocal Endomicroscope With Fluorescein Imaging Agent in the Colon

NCT03220711

Terminated 72 enrolled University of Michigan
NaSingle-groupOpen-labelDevice feasibility

Summary

The overall aim of this research project is to evaluate the imaging performance of a confocal endomicroscope. Fluorescein, an FDA-approved topical fluorescent dye, will be used to provide topical mucosal contrast. The purpose of this instrument is to provide real-time endoscopic "histology" to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient study group. This endomicroscope probe will be used during colonoscopies in subjects with colonic dysplasia, known colonic adenomatous polyps scheduled for endoscopic resection, or suspected dysplasia in subjects with Inflammatory Bowel Disease (IBD).

Timeline

Start
2017-07-28
Primary completion
2022-06-02
Completion
2022-06-02

Drugs

EvaluationDrugModalityDoseRoute
Background Fluorescein Diagnostic / imaging agent Other