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Completed

NCT Number: NCT03440047

Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim

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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Key information

Conditions

Gastro-Intestinal Disorder Digestive System Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida, Jacksonville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients age 18-100 undergoing planned upper or lower endoscopy at Mayo Clinic Rochester
  • Informed Consent

Exclusion criteria

  • Patient unwilling to provide informed consent

Treatment and study plan

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

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).

Primary outcomes

  1. Number of Subjects Whose Endoscopic Images Correlated With Final Clinical and Histological Diagnosis

    Time frame: Approximately one year

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Fujifilm Medical Systems USA, Inc.

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Feb 20, 2018
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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