Study Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This clinical study will consist of acquisition of images, followed by a reader study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- 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: Not seen; poor but usable, characteristic features are detectable but details are not fully reproduced; features just visible; good; allows an adequate assessment, details of anatomical structures are visible but not necessarily clearly defined; details emerging; 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.
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic AZ | Scottsdale | Arizona | United States | 85259 |
Sponsors and Collaborators
- Fujifilm Medical Systems USA, Inc.
Investigators
- Study Director: Aiji Matsunuma, FUJIFILM Medical Systems, U.S.A., Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P-16-004
Study Results
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 Detail | 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). |
| Arm/Group Title | Single Endoscopy Procedure |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 20 |
| COMPLETED | 20 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Single Endoscopy Procedure |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 20 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
18
90%
|
| >=65 years |
2
10%
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
58.6
|
| Sex: Female, Male (Count of Participants) | |
| Female |
11
55%
|
| Male |
9
45%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
2
10%
|
| Not Hispanic or Latino |
17
85%
|
| Unknown or Not Reported |
1
5%
|
| Region of Enrollment (participants) [Number] | |
| United States |
20
100%
|
Outcome Measures
| Title | Image Quality Scores Using Likert Scale |
|---|---|
| Description | 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: Not seen; poor but usable, characteristic features are detectable but details are not fully reproduced; features just visible; good; allows an adequate assessment, details of anatomical structures are visible but not necessarily clearly defined; details emerging; 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Single Endoscopy Procedure |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 20 |
| BLI |
3.3
(0.2)
|
| BLI-brt |
3.5
(0.1)
|
| FICE Setting 1 |
3.4
(0.1)
|
| FICE Setting 2 |
3.5
(0.1)
|
| FICE Setting 6 |
3.5
(0.0)
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Single Endoscopy Procedure | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Single Endoscopy Procedure | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | |
Serious Adverse Events |
||
| Single Endoscopy Procedure | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Single Endoscopy Procedure | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Randy Vader |
|---|---|
| Organization | Fujifilm Medical Systems USA, Inc. |
| Phone | (360) 356-6821 |
| randy.vader@fujifilm.com |
- P-16-004