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

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).

Study Overview

• Status: Terminated
• Conditions: Adenomatous Polyps; Irritable Bowel Disease; Colonic Dysplasia
• Intervention / Treatment: Device: confocal endomicroscope; Drug: Fluorescein

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).

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Subjects with abnormal colon tissue; The study subjects will be high-risk for colonic adenomas (i.e. strong family history of adenomas/adenocarcinoma or personal history of adenomas/adenocarcinoma), known adenoma scheduled for endoscopic resection, or in subjects with suspected dysplasia in inflammatory bowel disease (IBD). Fluorescein will be sprayed on the area of interest to provide imaging contrast for the images taken with the confocal endomicroscope.

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.; Other Names: Fluorescite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	five minutes

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2017
• Primary Completion (Actual): June 2, 2022
• Study Completion (Actual): June 2, 2022

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Adenoma; Irritable Bowel Syndrome; Adenomatous Polyps
• Other Study ID Numbers: HUM00124968

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No