Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim

Not Applicable

Completed

• Conditions: Gastro-Intestinal Disorder
• Interventions: Device: Fuji Flim Processor VP-7000, Light Source BL-7000

• Registration Number: NCT03440047
• Lead Sponsor: Mayo Clinic

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.

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.

Study Timeline

• Study Start: 2017-08-28
• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2018-02-14
• Study First Posted: 2018-02-20
• Primary Completion: 2022-12-05
• Study Completion: 2023-03-01
• Status Verified: 2023-09
• Results First Submitted: 2023-09-07
• Results First Submitted QC: 2023-09-29
• Last Update Submitted: 2023-09-29
• Results First Posted: 2023-10-03
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

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

Exclusion Criteria

1. Patient unwilling to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Subjects Whose Endoscopic Images Correlated With Final Clinical and Histological Diagnosis	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.

Trial Locations

Locations (2)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States