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

Not Applicable

Terminated

• Conditions: Adenomatous Polyps; Colonic Dysplasia; Irritable Bowel Disease
• Interventions: Device: confocal endomicroscope; Drug: Fluorescein

• Registration Number: NCT03220711
• Lead Sponsor: University of Michigan

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).

Study Timeline

• Study First Submitted: 2017-07-14
• Study First Submitted QC: 2017-07-14
• Study First Posted: 2017-07-18
• Study Start: 2017-07-28
• Primary Completion: 2022-06-02
• Study Completion: 2022-06-02
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with abnormal colon tissue	Fluorescein	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.
Subjects with abnormal colon tissue	confocal endomicroscope	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States