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

Adenomatous Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03220711
• Other study ID #: HUM00124968
• Status: Terminated
• Phase: N/A
• Start date: July 28, 2017
• Est. completion date: June 2, 2022

Study information

• Verified date: November 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: June 2, 2022
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomatous Polyps
• Colonic Dysplasia
• Irritable Bowel Disease
• Irritable Bowel Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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