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

Endoscopy Clinical Trial

— BLI  

Official title:

A Concurrence Study of Diagnostic Visualization Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755285
• Other study ID #: P-16-004
• Status: Completed
• Phase: N/A
• Start date: August 18, 2016
• Est. completion date: October 9, 2016

Study information

• Verified date: May 2020
• Source: Fujifilm Medical Systems USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 9, 2016
• Est. primary completion date: September 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Endoscopy

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic AZ	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Fujifilm Medical Systems USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Not seen; poor but usable, characteristic features are detectable but details are not fully reproduced; features just visible; good; allows an adequate assessment, details of anatomical structures are visible but not necessarily clearly defined; details emerging; 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.	Two to three months