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

Adenomatous Polyps Clinical Trial

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

Clinical Trial 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).

Clinical Trial Description

The device is being tested in small groups of individuals: generally less than 10 for each of a variety of histologically different colonic lesions or diseases (eg. IBD, adenomas, sessile seriated adenomas (SSAs), hyperplastic polyps, normal tissue). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03220711
Study type Interventional
Source University of Michigan
Contact
Status Terminated
Phase N/A
Start date July 28, 2017
Completion date June 2, 2022
View Details
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