Routine Endoscopy
Conditions
Keywords
FICE, NBI
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.
Detailed description
No additional description required.
Interventions
DEVICEFICE Image Acquisition followed by NBI Image Acquisition
Images Captured with FICE Device, followed by same locations imaged with NBI Image Acquisition System
Sponsors
Fujifilm Medical Systems USA, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Quality Scores Using Likert Scale | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| FICE Image Acquisition Followed by NBI Image Acquisition Images Captured with FICE Image Acquisition System immediately followed by Image Acquisition with NBI
FICE Image Acquisition System: Images Captured with FICE Device | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | FICE Image Acquisition Followed by NBI Image Acquisition |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants |
| Race/Ethnicity, Customized Asian | 3 participants |
| Race/Ethnicity, Customized Black or African American | 1 participants |
| Race/Ethnicity, Customized More than one race | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 participants |
| Race/Ethnicity, Customized White | 16 participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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
Time frame: One day
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FICE Image Acquisition Followed by NBI Image Acquisition | Image Quality Scores Using Likert Scale | FICE 0 | 3.2 units on a scale | Standard Deviation 0.7 |
| FICE Image Acquisition Followed by NBI Image Acquisition | Image Quality Scores Using Likert Scale | FICE 1 | 3.3 units on a scale | Standard Deviation 0.7 |
| FICE Image Acquisition Followed by NBI Image Acquisition | Image Quality Scores Using Likert Scale | FICE 2 | 3.4 units on a scale | Standard Deviation 0.6 |
| FICE Image Acquisition Followed by NBI Image Acquisition | Image Quality Scores Using Likert Scale | FICE 3 | 3.3 units on a scale | Standard Deviation 0.7 |
| FICE Image Acquisition Followed by NBI Image Acquisition | Image Quality Scores Using Likert Scale | FICE 4 | 3.3 units on a scale | Standard Deviation 0.8 |
| FICE Image Acquisition Followed by NBI Image Acquisition | Image Quality Scores Using Likert Scale | FICE 5 | 3.1 units on a scale | Standard Deviation 0.8 |
| FICE Image Acquisition Followed by NBI Image Acquisition | Image Quality Scores Using Likert Scale | FICE 9 | 3.2 units on a scale | Standard Deviation 0.8 |
| FICE Image Acquisition Followed by NBI Image Acquisition | Image Quality Scores Using Likert Scale | FICE 6 | 3.4 units on a scale | Standard Deviation 0.7 |
| FICE Image Acquisition Followed by NBI Image Acquisition | Image Quality Scores Using Likert Scale | FICE 7 | 3.0 units on a scale | Standard Deviation 0.8 |
| FICE Image Acquisition Followed by NBI Image Acquisition | Image Quality Scores Using Likert Scale | FICE 8 | 3.1 units on a scale | Standard Deviation 0.7 |
| FICE Image Acquisition Followed by NBI Image Acquisition | Image Quality Scores Using Likert Scale | NBI | 3.1 units on a scale | Standard Deviation 1.1 |
Comparison: All 20 subjects enrolled in the study, including Subject 219 that was dropped from the Reader assessments due to corrupted images, were all rated as having similar white light images between the FICE and NBI procedures for each location used in the concurrence study. This assessment was intended to assure that no procedural sequence or visualization bias was introduced into the image acquisition process. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).