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An external evaluation to obtain clinical data to create sample clinical images.
The data will also be used for product and technology development, marketing materials, and inclusion in publications.
The image data were assessed using a Likert scale for image quality sufficient for diagnostic assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac | Experimental | Revolution CT Cardiac Imaging Scan |
|
| Body/Extremity | Experimental | Revolution CT Body and/or Extremity Imaging Scan |
|
| Neuro | Experimental | Revolution CT Brain and Spinal Cord Imaging Scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revolution CT Scanner | Device | These scans would be considered "standard of care" but, because the subjects are scanned on an uncleared device they are investigational. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality | Image quality assessment on a 5 point Likert Scale: 5= Diagnostic- Excellent Image Quality 4= Diagnostic- Good Image Quality 3= Diagnostic-Acceptable Image Quality 2= Sub-Optimal Diagnostic with limited additional clinical information 1= Non-Diagnostic | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
• Subjects previously enrolled in this Evaluation.
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Curry, MD | Baptist South Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist South Florida Hospital | Miami | Florida | 33143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Scan | This is a single arm clinical trial. Standard of care scan Investigational Scan |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Scan | This is a single arm clinical trial. Standard of care scan Investigational Scan |
| 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 | Image quality assessment on a 5 point Likert Scale: 5= Diagnostic- Excellent Image Quality 4= Diagnostic- Good Image Quality 3= Diagnostic-Acceptable Image Quality 2= Sub-Optimal Diagnostic with limited additional clinical information 1= Non-Diagnostic | All cases were sufficient and had acceptable, good or excellent image quality | Posted | Mean | Standard Deviation | units on a scale | 24 hours | Scan Images | Participants |
|
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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 | Standard of Care Scan | This is a single arm clinical trial. Standard of care scan Investigational Scan |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomitting | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| RIchard Petrisko | GE Healthcare | 262-548-4637 | richard.petrisko@ge.com |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Neuro | Subjects receiving Revolution CT Scans of Brain or Spinal Cord |
|
|
| 0 |
| 49 |
| 1 |
| 49 |
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