Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)
FICE
A Concurrence Study of Diagnostic Visualization Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 26, 2013
CompletedFirst Posted
Study publicly available on registry
December 9, 2013
CompletedResults Posted
Study results publicly available
March 28, 2017
CompletedMarch 28, 2017
February 1, 2017
1 month
November 26, 2013
August 17, 2015
February 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Image Quality Scores Using Likert Scale
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
One day
Study Arms (1)
FICE Imaging System followed by NBI
OTHERImages 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.
Interventions
Images Captured with FICE Device, followed by same locations imaged with NBI Image Acquisition System
Eligibility Criteria
You may qualify if:
- Referred for diagnostic endoscopy or colonoscopy
- Ability to comply and willingness to partake in study
You may not qualify if:
- less than 21 years of age
- is an inmate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mayo Clinic, Arizona
Scottsdale, Arizona, 85259, United States
Results Point of Contact
- Title
- Robert Uzenoff: Executive Director of Clinical Science
- Organization
- FujiFilm Medical Systems USA
Study Officials
- STUDY DIRECTOR
Mary Moore
FujiFilm Medical Systems USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2013
First Posted
December 9, 2013
Study Start
October 1, 2013
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
March 28, 2017
Results First Posted
March 28, 2017
Record last verified: 2017-02