Endoscopy Clinical Trial
— BLIOfficial title:
A Concurrence Study of Diagnostic Visualization Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE)
Verified date | May 2020 |
Source | Fujifilm Medical Systems USA, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | October 9, 2016 |
Est. primary completion date | September 23, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic AZ | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Fujifilm Medical Systems USA, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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: 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. |
Two to three months |
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