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

Primary Purpose

Colonic Dysplasia, Adenomatous Polyps, Irritable Bowel Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
confocal endomicroscope
Fluorescein
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Colonic Dysplasia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects with abnormal colon tissue

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2017
Last Updated
November 17, 2022
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03220711
Brief Title
Study of Performance of Confocal Endomicroscope With Fluorescein Imaging Agent in the Colon
Official Title
Study of Performance of Confocal Endomicroscope With Fluorescein Imaging Agent in the Colon
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to equipment breakage and lack of funding.
Study Start Date
July 28, 2017 (Actual)
Primary Completion Date
June 2, 2022 (Actual)
Study Completion Date
June 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Dysplasia, Adenomatous Polyps, Irritable Bowel Disease

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects with abnormal colon tissue
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
confocal endomicroscope
Intervention Description
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
Drug
Intervention Name(s)
Fluorescein
Other Intervention Name(s)
Fluorescite
Intervention Description
Fluorescent dye used for imaging contrast only.
Primary Outcome Measure Information:
Title
Depth-imaging capability of the confocal endomicroscope using an imaging contrast agent, fluorescein
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Kim Turgeon, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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