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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03500757

Enrollment

Registered

2018-04-18

Start date

2018-04-29

Completion date

2022-05-16

Last updated

2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Percutaneous Tumor Ablation

Keywords

HoloLens, 3D holographic guidance

Brief 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.

Interventions

DEVICEHoloLens

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Standard System Usability Score on a Likert Scale	1 day	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026