Intra-procedural 360-degree Display for Performing Percutaneous Liver Tumor Ablation

Study Overview
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Brief Summary
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Medical images used to guide treatment of tumor(s) are presently displayed on flat-panel monitors (like screens used with computers). This protocol will evaluate, using a new headset to view the images in true 3D (360 degrees), while using standard flat panel monitors as usual (in accordance with standard of care). The headset is combined with a mini-global positioning system (GPS)-like system to help navigate to treat tumor(s). This evaluation is to show that the headset has potential to provide guidance and navigation information that can improve the treatment of tumor(s) with heat.

Detailed Description
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This protocol will clinically evaluate new 3D holographic guidance and navigation for percutaneous ablation of solid tumors to ultimately overcome limitations of displaying images on 2D flat-panel monitors (flat screens). 3D Holographic percutaneous ablation (3D HPA) provides real-time, 360° visualization for guidance and navigation of tracked interventional instruments augmented to the operative site. In this preliminary protocol, 3D HPA will be evaluated as an adjunct to flat-screen display of conventional images used for guidance (ultrasound, fluoroscopy, CT), in accordance with standard of care.

Official Title
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Intra-procedural 360-degree Display for Performing Percutaneous Liver Tumor Ablation as an Adjunct to Standard Flat Panel Display

Conditions
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Percutaneous Tumor Ablation

Intervention / Treatment
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* Device: HoloLens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not pregnant Willing and able to give informed consent prior to enrollment. This includes media release form. Has met all criteria to undergo percutaneous tumor ablation. Exclusion Criteria: Not willing or able to give informed consent Patients with pacemakers or automated implantable cardioverter defibrillator (AICDs).

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| 360-degree Display of solid tumors<br>Evaluate the feed back of using the HoloLens headset to have a 360 degree visualization of patient tumors during percutaneous liver tumor ablation | Device: HoloLens<br>* use the HoloLens to evaluate new 3D holographic guidance and navigation for percutaneous ablation of solid tumors<br>* Other names: headset;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard System Usability Score on a Likert Scale | The surgeons and staff completing the intervention will rate the usability of the system. An average score greater than 3 will indicate acceptability of the 360 degree display. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HoloLens, 3D holographic guidance