Trial Outcomes & Findings for Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI) (NCT NCT02005393)
NCT ID: NCT02005393
Last Updated: 2017-03-28
Results Overview
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
COMPLETED
NA
20 participants
One day
2017-03-28
Participant Flow
Twenty subjects were recruited at Mayo Clinic, Scottsdale between 23Oct2013 and 08Nov2013 to have two endoscopies completed - one using Fujifilm's endoscope and processor equipped with FICE, and the second immediately following with Olympus' endoscope and processor equipped with NBI.
Participant milestones
| Measure |
FICE Image Acquisition Followed by NBI Image Acquisition
Images Captured with FICE Image Acquisition immediately followed by NBI Image Acquisition
FICE Image Acquisition System: Images Captured with FICE Device
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)
Baseline characteristics by cohort
| Measure |
FICE Image Acquisition Followed by NBI Image Acquisition
n=20 Participants
Images Captured with FICE Image Acquisition System immediately followed by Image Acquisition with NBI
FICE Image Acquisition System: Images Captured with FICE Device
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
16 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: One dayPopulation: All patients had imaging done with both FICE, immediately followed by NBI. Images for one subject were not included in the Reader Study due to an error on the Compact Flash card which resulted in three (3) corrupt FICE images (FICE settings 0, 1 \& 2); therefore making 19 out of 20 participants analyzed.
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
Outcome measures
| Measure |
FICE Image Acquisition Followed by NBI Image Acquisition
n=19 Participants
Images Captured with FICE Image Acquisition System, immediately followed by NBI Image Acquisition; always in that order.
FICE Image Acquisition System: Images Captured with FICE Device
|
|---|---|
|
Image Quality Scores Using Likert Scale
FICE 0
|
3.2 units on a scale
Standard Deviation 0.7
|
|
Image Quality Scores Using Likert Scale
FICE 1
|
3.3 units on a scale
Standard Deviation 0.7
|
|
Image Quality Scores Using Likert Scale
FICE 2
|
3.4 units on a scale
Standard Deviation 0.6
|
|
Image Quality Scores Using Likert Scale
FICE 3
|
3.3 units on a scale
Standard Deviation 0.7
|
|
Image Quality Scores Using Likert Scale
FICE 4
|
3.3 units on a scale
Standard Deviation 0.8
|
|
Image Quality Scores Using Likert Scale
FICE 5
|
3.1 units on a scale
Standard Deviation 0.8
|
|
Image Quality Scores Using Likert Scale
FICE 6
|
3.4 units on a scale
Standard Deviation 0.7
|
|
Image Quality Scores Using Likert Scale
FICE 7
|
3.0 units on a scale
Standard Deviation 0.8
|
|
Image Quality Scores Using Likert Scale
FICE 8
|
3.1 units on a scale
Standard Deviation 0.7
|
|
Image Quality Scores Using Likert Scale
FICE 9
|
3.2 units on a scale
Standard Deviation 0.8
|
|
Image Quality Scores Using Likert Scale
NBI
|
3.1 units on a scale
Standard Deviation 1.1
|
Adverse Events
FICE Image Acquisition Followed by NBI Image Acquisition
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert Uzenoff: Executive Director of Clinical Science
FujiFilm Medical Systems USA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60