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Philips Healthcare has added a virtual path planner to the current commercially available XperGuide software platform and that has the potential to significantly reduce dose during image-guided needle interventions.
The investigational device is used for image guidance by virtually planned path and X-ray data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XperGuide | Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data). |
| |
| XperGuide with virtual path planning | Image-guided needle procedures with XperGuide with virtual path planning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XperGuide | Radiation | Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Scale (SUS) Score as a Measure of Qualitative Clinical Usefulness | Evaluate the workflow, usability, and clinical impact of device by assessing clinical outcome and success of the procedures. The SUS is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability developed by Brooke, J. The user needs to provide agreement or disagreement for the 10 statements. After the appearing of the SUS in literature and once part of the ISO standard ISO 9241 Part 11 it has become an industry standard and has been used for over 25 years to measure usability. The minimum score is 0 and the maximum core is 100. Analysis of 500 studies with SUS showed that the average SUS score is a 68. A SUS score above a 68 would be considered above average and anything below 68 is below average | Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest |
| Measure | Description | Time Frame |
|---|---|---|
| Fluoroscopy Time | Measure fluoroscopy time (minutes) needed during needle interventional procedure and compare the collected results with existing data from needle interventional procedures performed using XperGuide alone. | Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest |
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Inclusion Criteria:
Exclusion Criteria:
-Pregnant patients.
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Patients of all ages. Patient weight is limited to the specification of the patient table.
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| Name | Affiliation | Role |
|---|---|---|
| John Racadio, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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The enrollment of patients occurred between December 3rd 2013 and June 9th 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | XperGuide | Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data). XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT. |
| FG001 | XperGuide With Virtual Path Planning | Image-guided needle procedures with XperGuide with virtual path planning XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | XperGuide | Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data) XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT. |
| BG001 | XperGuide With Virtual Path Planning |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | System Usability Scale (SUS) Score as a Measure of Qualitative Clinical Usefulness | Evaluate the workflow, usability, and clinical impact of device by assessing clinical outcome and success of the procedures. The SUS is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability developed by Brooke, J. The user needs to provide agreement or disagreement for the 10 statements. After the appearing of the SUS in literature and once part of the ISO standard ISO 9241 Part 11 it has become an industry standard and has been used for over 25 years to measure usability. The minimum score is 0 and the maximum core is 100. Analysis of 500 studies with SUS showed that the average SUS score is a 68. A SUS score above a 68 would be considered above average and anything below 68 is below average | SUS Score is only assessed for new technology (arm/group: XperGuide with virtual path planning) | Posted | Mean | Standard Deviation | Scores on a scale | Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest |
|
During procedure
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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 | XperGuide | Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data). XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rami Nachabe, PhD | Philips | +1-513-926-1486 | Rami.Nachabe@philips.com |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D001847 | Bone Diseases |
| D009135 | Muscular Diseases |
| D013122 | Spinal Diseases |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| XperGuide with virtual path planning | Radiation | Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff. |
|
Image-guided needle procedures with XperGuide with virtual path planning XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | XperGuide With Virtual Path Planning | Image-guided needle procedures with XperGuide with virtual path planning XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff. |
|
|
| Secondary | Fluoroscopy Time | Measure fluoroscopy time (minutes) needed during needle interventional procedure and compare the collected results with existing data from needle interventional procedures performed using XperGuide alone. | Posted | Median | Full Range | Minutes | Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | XperGuide With Virtual Path Planning | Image-guided needle procedures with XperGuide with virtual path planning XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff. | 0 | 12 | 0 | 12 |
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| D002318 | Cardiovascular Diseases |