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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.
This clinical study will consist of acquisition of images, followed by a reader study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Endoscopy Procedure | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Endoscopy Procedure | Device | 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 | Description | Time Frame |
|---|---|---|
| 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:
This was a blinded and randomized Reader assessment of all BLI and FICE images. | Two to three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aiji Matsunuma | FUJIFILM Medical Systems, U.S.A., Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic AZ | Scottsdale | Arizona | 85259 | United States |
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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).
Subjects enrolled had been referred to Mayo Clinic for clinically indicated gastrointestinal diagnostic endoscopy between August 19, 2016 and September 7, 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 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:
This was a blinded and randomized Reader assessment of all BLI and FICE images. | 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. | Posted | Mean | Standard Deviation | units on a scale | Two to three months |
|
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randy Vader | Fujifilm Medical Systems USA, Inc. | (360) 356-6821 | randy.vader@fujifilm.com |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| Participants |
| No |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | 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. |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D013514 | Surgical Procedures, Operative |