Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195, United States
Completed
NCT Number: NCT03500757
Intra-procedural 360-degree Display for Performing Percutaneous Liver Tumor Ablation
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
HoloLens
Deviceuse the HoloLens to evaluate new 3D holographic guidance and navigation for percutaneous ablation of solid tumors
Other names: headset
Primary outcomes
-
Standard System Usability Score on a Likert Scale
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Case Comprehensive Cancer Center
Other
Registry information
Official study title
Intra-procedural 360-degree Display for Performing Percutaneous Liver Tumor Ablation as an Adjunct to Standard Flat Panel Display
Important dates
- Study start
- 2018
- Primary completion
- 2020
- Study completion
- 2022
- First posted
- Apr 18, 2018
- Registry last updated
- Jul 8, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.