Endoscopy
Conditions
Keywords
BLI, FICE
Brief summary
The study is intended to demonstrate substantial equivalence of visualization using BLI to the predicate device, FICE, so as to support the addition of BLI as an adjunct to white light imaging in the company's video processor.
Detailed description
This clinical study will consist of acquisition of images, followed by a reader study.
Interventions
DEVICESingle Endoscopy Procedure
All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject.
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 clinically indicated gastrointestinal diagnostic endoscopy * Ability to understand the requirements of the study, to provide written informed consent and to comply with the study protocol * Ability to understand and provide written authorization for the use and disclosure of protected health information (PHI) per the Health Insurance Portability and Accountability Act (HIPAA) privacy ruling.
Exclusion criteria
* Under the age of 21 years * Is an inmate (see US Code of Federal Regulations 45 C.F.R. 46.306)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Quality Scores Using Likert Scale | Two to three months | Likert score ratings of image quality for Blue Light Imaging (BLI), Blue Light Imaging-bright (BLI-brt) and Flexible spectral-Imaging Color Enhancement (FICE) images. Each BLI and BLI-Brt setting was compared to FICE, to determine which settings were equivalent to FICE. Likert Score Scale: 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 assessment, anatomical details are clearly defined; details clear This was a blinded and randomized Reader assessment of all BLI and FICE images. |
Countries
United States
Participant flow
Recruitment details
Subjects enrolled had been referred to Mayo Clinic for clinically indicated gastrointestinal diagnostic endoscopy between August 19, 2016 and September 7, 2016.
Pre-assignment details
Each subject underwent a complete diagnostic endoscopy examination with white light, followed by an exam with BLI (BLI + BLI-brt) and FICE, at 3 FICE settings (1,2 & 6). Each subject could contribute up to 2 anatomical sites (regions of interest).
Participants by arm
| Arm | Count |
|---|---|
| Single Endoscopy Procedure All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject.
Single Endoscopy Procedure: All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Single Endoscopy Procedure |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 58.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| 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 Blue Light Imaging (BLI), Blue Light Imaging-bright (BLI-brt) and Flexible spectral-Imaging Color Enhancement (FICE) images. Each BLI and BLI-Brt setting was compared to FICE, to determine which settings were equivalent to FICE. Likert Score Scale: 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 assessment, anatomical details are clearly defined; details clear This was a blinded and randomized Reader assessment of all BLI and FICE images.
Time frame: Two to three months
Population: All patients had imaging done with white light (standard) as well as BLI, BLI-brt, and FICE. Each of the three (3) Readers had a unique set of randomized images which they reviewed independently during the reader study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Endoscopy Procedure | Image Quality Scores Using Likert Scale | BLI | 3.3 units on a scale | Standard Deviation 0.2 |
| Single Endoscopy Procedure | Image Quality Scores Using Likert Scale | BLI-brt | 3.5 units on a scale | Standard Deviation 0.1 |
| Single Endoscopy Procedure | Image Quality Scores Using Likert Scale | FICE Setting 1 | 3.4 units on a scale | Standard Deviation 0.1 |
| Single Endoscopy Procedure | Image Quality Scores Using Likert Scale | FICE Setting 2 | 3.5 units on a scale | Standard Deviation 0.1 |
| Single Endoscopy Procedure | Image Quality Scores Using Likert Scale | FICE Setting 6 | 3.5 units on a scale | Standard Deviation 0 |