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

Not Applicable

Completed

• Conditions: Endoscopy
• Interventions: Device: Single Endoscopy Procedure

• Registration Number: NCT02755285
• Lead Sponsor: Fujifilm Medical Systems USA, Inc.

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-28
• Study Start: 2016-08-18
• Primary Completion: 2016-09-23
• Study Completion: 2016-10-09
• Results First Submitted: 2020-03-27
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-05
• Results First Posted: 2020-05-19
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Endoscopy Procedure	Single Endoscopy Procedure	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.

Primary Outcome Measures

Name	Time	Method
Image Quality Scores Using Likert Scale	Two to three months	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.

Trial Locations

Locations (1)

Mayo Clinic AZ; 🇺🇸 Scottsdale, Arizona, United States