Percutaneous Tumor AblationNCT03500757
Intra-procedural 360-degree Display for Performing Percutaneous Liver Tumor Ablation
An observational study of Percutaneous Tumor Ablation, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Tumor Ablation
- What is being tested?
- HoloLens
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2018to 16 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Not willing or able to give informed consent
- Patients with pacemakers or automated implantable cardioverter defibrillator (AICDs).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Intra-procedural 360-degree Display for Performing Percutaneous Liver Tumor Ablation as an Adjunct to Standard Flat Panel Display
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.
- Conditions
- Percutaneous Tumor Ablation
- Being tested
- HoloLens
- Keywords
- HoloLens, 3D holographic guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoloLensDevice
Also called headset
use the HoloLens to evaluate new 3D holographic guidance and navigation for percutaneous ablation of solid tumors
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: HoloLens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start29 Apr 2018
- Primary completion17 Aug 2020
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Tumor AblationStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Martin III, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500757
- Sponsor's protocol ID
- CASE1218
- Status last verified
- Jul 2025
- First submitted
- 10 Apr 2018
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-procedural 360-degree Display for Performing Percutaneous Liver Tumor Ablation as an Adjunct to Standard Flat Panel Display
- ClinicalTrials.gov ID
- NCT03500757
- Acronym / sponsor ID
- CASE1218
- Conditions
- Percutaneous Tumor Ablation
- Keywords
- HoloLens, 3D holographic guidance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 29 Apr 2018 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 360-degree Display of solid tumors | – | Device: HoloLensEvaluate the feed back of using the HoloLens headset to have a 360 degree visualization of patient tumors during percutaneous liver tumor ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Not willing or able to give informed consent
- Patients with pacemakers or automated implantable cardioverter defibrillator (AICDs).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HoloLensAlso: headsetuse the HoloLens to evaluate new 3D holographic guidance and navigation for percutaneous ablation of solid tumors | Device | 360-degree Display of solid tumors |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Martin III, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Tumor Ablation, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard System Usability Score on a Likert Scale (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.