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OpenTrials
Completed

NCT Number: NCT02755285

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

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.

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Key information

Conditions

Endoscopy

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic AZ

Scottsdale, Arizona, 85259, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Single Endoscopy Procedure

Device

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 outcomes

  1. Image Quality Scores Using Likert Scale

    Time frame: 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:

    • 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.

Sponsors and collaborators

Lead sponsor

Fujifilm Medical Systems USA, Inc.

Industry

Registry information

Official study title

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

Acronym: BLI

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 28, 2016
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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