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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan

Criteria

Inclusion Criteria:

Subject meets at least one of the following criteria:

• At increased risk for colorectal cancer and colonic polyps

• Known colonic adenomas scheduled for colonic polyp resection

• Scheduled for outpatient colonoscopy for follow up surveillance of IBD with known dysplasia or who are at high risk for high grade dysplasia.

Exclusion Criteria:

Subject meets all of the following criteria:

• Subject is scheduled for outpatient colonoscopy in the Medical Procedures Unit at University of Michigan Health System.

• Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) Standard practice guidelines for safely proceeding with the procedure will be sufficient for our study.

• Age 18 to 100 years

• Willing and able to sign informed consent