Colonic Dysplasia, Adenomatous Polyps, Irritable Bowel Disease
Conditions
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).
Interventions
DEVICEconfocal endomicroscope
This instrument provides real-time endoscopic histology to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient study group during colonoscopies.
DRUGFluorescein
Fluorescent dye used for imaging contrast only.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depth-imaging capability of the confocal endomicroscope using an imaging contrast agent, fluorescein | five minutes | 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. |
Countries
United States
Outcome results
None listed