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

NCT ID: NCT03500757

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-29

Study Completion Date

2022-05-16

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.

Conditions

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Percutaneous Tumor Ablation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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360-degree Display of solid tumors

Evaluate the feed back of using the HoloLens headset to have a 360 degree visualization of patient tumors during percutaneous liver tumor ablation

HoloLens

Intervention Type DEVICE

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

Interventions

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HoloLens

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

Intervention Type DEVICE

Other Intervention Names

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headset

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Martin III, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Case Comprehensive Cancer Center

Locations

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Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CASE1218

Identifier Type: -

Identifier Source: org_study_id

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