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

Percutaneous Tumor Ablation Clinical Trial

Official title:

Intra-procedural 360-degree Display for Performing Percutaneous Liver Tumor Ablation as an Adjunct to Standard Flat Panel Display

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03500757
• Other study ID #: CASE1218
• Status: Enrolling by invitation
• Start date: April 29, 2018
• Est. completion date: August 1, 2024

Study information

• Verified date: March 2024
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Liver Neoplasms
• Percutaneous Tumor Ablation

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day