Study Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE)

Fujifilm Medical Systems USA, Inc.20 enrolled

Overview

The study is intended to demonstrate substantial equivalence of visualization using BLI to the predicate device, FICE, so as to support the addition of BLI as an adjunct to white light imaging in the company's video processor.

This clinical study will consist of acquisition of images, followed by a reader study.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Endoscopy

Interventions

Single Endoscopy ProcedureDEVICE

All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject.

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Referred for clinically indicated gastrointestinal diagnostic endoscopy * Ability to understand the requirements of the study, to provide written informed consent and to comply with the study protocol * Ability to understand and provide written authorization for the use and disclosure of protected health information (PHI) per the Health Insurance Portability and Accountability Act (HIPAA) privacy ruling. Exclusion Criteria: * Under the age of 21 years * Is an inmate (see US Code of Federal Regulations 45 C.F.R. 46.306)

Locations (1)

Mayo Clinic AZ

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

Image Quality Scores Using Likert Scale

Likert score ratings of image quality for Blue Light Imaging (BLI), Blue Light Imaging-bright (BLI-brt) and Flexible spectral-Imaging Color Enhancement (FICE) images. Each BLI and BLI-Brt setting was compared to FICE, to determine which settings were equivalent to FICE. Likert Score Scale: 1. Not seen; 2. poor but usable, characteristic features are detectable but details are not fully reproduced; features just visible; 3. good; allows an adequate assessment, details of anatomical structures are visible but not necessarily clearly defined; details emerging; 4. very good; allows an excellent assessment, anatomical details are clearly defined; details clear This was a blinded and randomized Reader assessment of all BLI and FICE images.

Time frame: Two to three months

Data from ClinicalTrials.gov

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