Virtual Path Planning for Image-guided Needle Interventions

Study Overview
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Brief Summary
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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.

Detailed Description
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The investigational device is used for image guidance by virtually planned path and X-ray data.

Official Title
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Evaluation of Adding Virtual Path Planning to the Philips FD20 XperGuide to Reduce Radiation Dose During Image-guided Needle Interventional Procedures.

Conditions
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Gastrointestinal Diseases, Bone Diseases, Muscular Diseases, Spinal Diseases, Vascular Diseases

Intervention / Treatment
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* Radiation: XperGuide
* Radiation: XperGuide with virtual path planning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at any age who are referred for a clinically indicated XperGuide interventional procedure. The informed consent has been signed by the participant, parent or legal guardian as appropriate. Exclusion Criteria: -Pregnant patients.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| XperGuide<br>Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data). | Radiation: XperGuide<br>* Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT.<br>|
| XperGuide with virtual path planning<br>Image-guided needle procedures with XperGuide with virtual path planning | Radiation: XperGuide with virtual path planning<br>* Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |