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

N/ATerminatedNCT03220711

University of Michigan72 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Colonic Dysplasia Adenomatous Polyps Irritable Bowel Disease

Interventions

confocal endomicroscopeDEVICE

This instrument provides real-time endoscopic "histology" to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient study group during colonoscopies.

FluoresceinDRUG

Fluorescent dye used for imaging contrast only.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Depth-imaging capability of the confocal endomicroscope using an imaging contrast agent, fluorescein

The test product efficacy will be assessed by evaluating the fluorescence intensities measured from suspicious regions of colonic mucosa where the agent is administered compared to adjacent normal mucosa.

Time frame: five minutes