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



Status:Enrolling by invitation
Conditions:Liver Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:April 29, 2018
End Date:December 2019

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

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.

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.

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).
We found this trial at
1
site
10201 Carnegie Avenue
Cleveland, Ohio 44195
Principal Investigator: Charles Martin III, MD
Phone: 216-445-5482
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mi
from
Cleveland, OH
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