Spots Global Cancer Trial Database for Study of Performance of Confocal Endomicroscope With Fluorescein Imaging Agent in the Colon

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Trial Identification

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

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

Study ID: NCT03220711

Conditions

Colonic Dysplasia

Adenomatous Polyps

Irritable Bowel Disease

Interventions

confocal endomicroscope

Fluorescein

Study Description

Brief 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).

Detailed 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).