NCT03500757

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Percutaneous Tumor Ablation

Interventions

Type	Name	Description
DEVICE	HoloLens	use the HoloLens to evaluate new 3D holographic guidance and navigation for percutaneous ablation of solid tumors

Timeline

• Start date: 2018-04-29
• Primary completion: 2020-08-17
• Completion: 2022-05-16
• First posted: 2018-04-18
• Last updated: 2025-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study