NCT03440047

Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gastro-Intestinal Disorder

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-08-28
• Primary completion: 2022-12-05
• Completion: 2023-03-01
• First posted: 2018-02-20
• Last updated: 2023-10-03
• Results posted: 2023-10-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study