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OpenTrials
Completed

NCT Number: NCT02005393

Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)

The study is intended to test the image quality of the FICE system to the predicate device, Narrow Band Imaging (NBI). The hypothesis is the images are of equal quality.

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Key information

Conditions

Routine Endoscopy

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Arizona

Scottsdale, Arizona, 85259, United States

About this study

No additional description required.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Referred for diagnostic endoscopy or colonoscopy
  • Ability to comply and willingness to partake in study

Exclusion criteria

  • less than 21 years of age
  • is an inmate

Treatment and study plan

FICE Image Acquisition followed by NBI Image Acquisition

Device

Images Captured with FICE Device, followed by same locations imaged with NBI Image Acquisition System

Primary outcomes

  1. Image Quality Scores Using Likert Scale

    Time frame: One day

    Likert score ratings of image quality for FICE and NBI images. Each FICE setting was compared to NBI, to determine which FICE settings were equivalent to NBI.

    Likert Scores:

    • 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 assesssment, anatomical details are clearly defined; details clear

Sponsors and collaborators

Lead sponsor

Fujifilm Medical Systems USA, Inc.

Industry

Registry information

Official study title

A Concurrence Study of Diagnostic Visualization Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)

Acronym: FICE

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 9, 2013
Registry last updated
Mar 28, 2017

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.