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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03500757
Recruitment Status : Enrolling by invitation
First Posted : April 17, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Percutaneous Tumor Ablation Device: HoloLens

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.

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Study Type : Observational
Estimated Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intra-procedural 360-degree Display for Performing Percutaneous Liver Tumor Ablation as an Adjunct to Standard Flat Panel Display
Actual Study Start Date : April 29, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Group/Cohort Intervention/treatment
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
use the HoloLens to evaluate new 3D holographic guidance and navigation for percutaneous ablation of solid tumors
Other Name: headset




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500757


Locations
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United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Charles Martin III, MD Cleveland Clinic, Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03500757     History of Changes
Other Study ID Numbers: CASE1218
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Case Comprehensive Cancer Center:
HoloLens
3D holographic guidance

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases