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CompletedNCT03500757Updated Jul 8, 2025

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

An observational study in Percutaneous Tumor Ablation, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Case Comprehensive Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
11
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Percutaneous Tumor Ablation

Keywords

  • HoloLens
  • 3D holographic guidance
03

In context

Lead sponsor

Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This device evaluation will include patients undergoing percutaneous thermal ablation of solid liver tumors at Cleveland Clinic as clinically indicated in the 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

Exclusion Criteria:

  • Not willing or able to give informed consent
  • Patients with pacemakers or automated implantable cardioverter defibrillator (AICDs).
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
11 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Device: HoloLens

Interventions

  • DeviceHoloLens

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

    Also known as: headset

06

What researchers measure

Primary outcomes

  1. Standard System Usability Score on a Likert Scale

    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.

    Time frame: 1 day

07

Study locations

1 site
  • Cleveland Clinic, Case Comprehensive Cancer Center
    Cleveland, Ohio 44195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03500757
Lead sponsor
Case Comprehensive Cancer Center
Responsible party
Sponsor
First posted
Apr 18, 2018
Start date
Apr 29, 2018
Primary completion
Aug 17, 2020
Completion
May 16, 2022
Last update
Jul 8, 2025

Study contacts

Charles Martin III, MD
principal investigator · Cleveland Clinic, Case Comprehensive Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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