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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.
No additional description required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FICE Imaging System followed by NBI | Other | Images Captured with FICE Image Acquisition System (experimental) followed by NBI Image Acquisition System (standard of care); always in that order. Imaging took place in esophagus, gastric, duodenum and/or colon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FICE Image Acquisition followed by NBI Image Acquisition | Device | Images Captured with FICE Device, followed by same locations imaged with NBI Image Acquisition System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| One day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Moore | FujiFilm Medical Systems USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic, Arizona | Scottsdale | Arizona | 85259 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| 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. | Posted | Mean | Standard Deviation | units on a scale | One day |
|
There were no AE's for this study, however an event would have been considered an AE from the time they started the procedure, until the patient life the hospital for the day.
No AE's (or SAE's) reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 No AE's |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Uzenoff: Executive Director of Clinical Science | FujiFilm Medical Systems USA | (203) 602-3664 | ruzenoff@fujifilm.com |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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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 |
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| 0 |
| 20 |
| 0 |
| 20 |
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