MedTrace Logo

Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim

NCT03440047 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2023-10-03

Study results available
· View outcomes & findings →

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.

Conditions

  • Gastro-Intestinal Disorder

Interventions

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).

Sponsors & Collaborators

  • Fujifilm Medical Systems USA, Inc.

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Nayantara Coelho-Prabhu, MBBS · Mayo Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2022-12-05
Completion
2023-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03440047 on ClinicalTrials.gov