Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim

NCT03440047 | Completed Results FDA Device

• 1 other identifier: 17-002101
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

endoscopic image; Fujifilm; Blue light imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Fuji Flim Processor VP-7000

EXPERIMENTAL

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

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

Interventions

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).

Fuji Flim Processor VP-7000

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Patient unwilling to provide informed consent

Sponsors & Collaborators

• Mayo Clinic: lead
• Fujifilm Medical Systems USA, Inc.: collaborator

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Digestive System Diseases

Results Point of Contact

• Title: Dr. Nayantara Coelho-Prabhu
• Organization: Mayo Clinic

CoelhoPrabhu.Nayantara@mayo.edu

(507)284-2407

Study Officials

• Nayantara Coelho-Prabhu, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: February 20, 2018
• Study Start: August 28, 2017
• Primary Completion: December 5, 2022
• Study Completion: March 1, 2023
• Last Updated: October 3, 2023
• Results First Posted: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)