drugset / Trial / NCT03220711
Study of Performance of Confocal Endomicroscope With Fluorescein Imaging Agent in the Colon
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Fluorescein | Diagnostic / imaging agent | — | Other |