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

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ClinicalTrials.gov Identifier: NCT02005393
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Fujifilm Medical Systems USA, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Routine Endoscopy Device: FICE Image Acquisition followed by NBI Image Acquisition Not Applicable

Detailed Description:
No additional description required.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Concurrence Study of Diagnostic Visualization Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)
Study Start Date : October 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
FICE Imaging System followed by NBI
Images Captured with FICE Image Acquisition System (experimental) followed by NBI Image Acquisition System (standard of care); always in that order. Imaging took place in esophagus, gastric, duodenum and/or colon.
Device: FICE Image Acquisition followed by NBI Image Acquisition
Images Captured with FICE Device, followed by same locations imaged with NBI Image Acquisition System




Primary Outcome Measures :
  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:

    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 assesssment, anatomical details are clearly defined; details clear



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005393


Locations
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United States, Arizona
Mayo Clinic, Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Fujifilm Medical Systems USA, Inc.
Investigators
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Study Director: Mary Moore FujiFilm Medical Systems USA

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Responsible Party: Fujifilm Medical Systems USA, Inc.
ClinicalTrials.gov Identifier: NCT02005393     History of Changes
Other Study ID Numbers: P-13-003
First Posted: December 9, 2013    Key Record Dates
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017
Last Verified: February 2017

Keywords provided by Fujifilm Medical Systems USA, Inc.:
FICE
NBI