NCT03220711

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Colonic Dysplasia
• Adenomatous Polyps
• Irritable Bowel Disease

Interventions

Type	Name	Description
DEVICE	confocal endomicroscope	This instrument provides real-time endoscopic "histology" to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient study group during colonoscopies.
DRUG	Fluorescein	Fluorescent dye used for imaging contrast only.

Timeline

• Start date: 2017-07-28
• Primary completion: 2022-06-02
• Completion: 2022-06-02
• First posted: 2017-07-18
• Last updated: 2022-11-22

Locations

1 site across 1 country: United States