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

• Conditions: Percutaneous Tumor Ablation
• Interventions: Device: HoloLens

• Registration Number: NCT03500757
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-18
• Study Start: 2018-04-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 15

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
360-degree Display of solid tumors	HoloLens	Evaluate the feed back of using the HoloLens headset to have a 360 degree visualization of patient tumors during percutaneous liver tumor ablation

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cleveland Clinic, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States