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NCT03440047 Clinical Trial

Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim

Gastro-Intestinal Disorder Clinical Trial

Official title:
Minimal Risk Registry of Endoscopic Image and Pathology Correlation Using Fujifilm 7000 Blue Light Imaging System With 4 Light-emitting Diode (LED) Multi Light Technology

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03440047
Other study ID # 17-002101
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 28, 2017
Est. completion date March 1, 2023

Study information
Verified date September 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to see if advanced endoscopic imaging may be helpful to accurately distinguish pathological tissue from normal tissue and guide therapy of endoscopically identified pathology.

Description:

In this registry, the Fujifilm 4-LED system, which is considered non significant risk, will be used for routine endoscopic procedures at Mayo Clinic Florida and Rochester. Where indicated and based on clinical standards of care, a biopsy or tissue removal will be performed. Immediately prior to tissue removal, a standard set of electronic images will be captured including white light, BLI, BLI-bright, LCI. Each image will be stored in high resolution lossless format and later correlated with the final clinical and histological diagnosis.

Recruitment information / eligibility
Status Completed
Enrollment 355
Est. completion date March 1, 2023
Est. primary completion date December 5, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: 1. All patients age 18-100 undergoing planned upper or lower endoscopy at Mayo Clinic Rochester 2. Informed Consent Exclusion Criteria: 1. Patient unwilling to provide informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Fuji Flim Processor VP-7000, Light Source BL-7000
Fujifilm's Digital Video Processor VP-7000 and LED Light Source BL-7000 is a class II Endoscopic Video Imaging System under 21 C.F.R. 876.1500. It is the next generation of Fujifilm's VP-4440HD Digital Video Processor with Flexible-spectral Imaging Color Enhancement (FICE) and Light Source (K140149).

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Fujifilm Medical Systems USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Subjects Whose Endoscopic Images Correlated With Final Clinical and Histological Diagnosis Subjects presenting with gastrointestinal mucosal disorders will have a biopsy based on clinical standard of care. Just prior to the biopsy, a standard set of electronic images will be captured using the Fujifilm 7000 Blue Light Imaging System with 4-LED Multi Light Technology. Images will be correlated with the final clinical and histological diagnosis of the gastrointestinal disorder. Approximately one year
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