Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Gastro-Intestinal Disorder

Intervention / Treatment
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* Device: Fuji Flim Processor VP-7000, Light Source BL-7000


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients age 18-100 undergoing planned upper or lower endoscopy at Mayo Clinic Rochester Informed Consent Exclusion Criteria: 1. Patient unwilling to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Registry of endoscopic image and pathology correlation of different pathological condition such as: inflammatory bowel disease, colon polyps
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fuji Flim Processor VP-7000<br>Screening or surveillance colonoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000 | Device: Fuji Flim Processor VP-7000, Light Source BL-7000<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic image, Fujifilm, Blue light imaging