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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-28

Study Completion Date

2022-06-02

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Colonic Dysplasia Adenomatous Polyps Irritable Bowel Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

confocal endomicroscope

Intervention Type DEVICE

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

Fluorescein

Intervention Type DRUG

Fluorescent dye used for imaging contrast only.

Interventions

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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.

Intervention Type DEVICE

Fluorescein

Fluorescent dye used for imaging contrast only.

Intervention Type DRUG

Other Intervention Names

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Fluorescite

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No