Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim

Mayo Clinic

Status: Completed

Conditions: Gastro-Intestinal Disorder

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03440047

17-002101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 355 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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355 participants in 1 patient group

Fuji Flim Processor VP-7000

Experimental group

Description:

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

Treatment:

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