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

NCT03220711 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-11-22

No results posted yet for this study

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).

Conditions

  • Colonic Dysplasia
  • Adenomatous Polyps
  • Irritable Bowel Disease

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Danielle Kim Turgeon, MD · University of Michigan

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-28
Primary Completion
2022-06-02
Completion
2022-06-02

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03220711 on ClinicalTrials.gov