Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-28

Study Completion Date

2023-03-01

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.

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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.

Conditions

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Gastro-Intestinal Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Registry of endoscopic image and pathology correlation of different pathological condition such as: inflammatory bowel disease, colon polyps

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fuji Flim Processor VP-7000

Screening or surveillance colonoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000

Group Type EXPERIMENTAL

Fuji Flim Processor VP-7000, Light Source BL-7000

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE