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Trial record 1 of 234 for:    Charles Martin
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Intra-procedural 360-degree Display for Performing Percutaneous Liver Tumor Ablation

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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

Tracking Information
First Submitted Date April 10, 2018
First Posted Date April 17, 2018
Last Update Posted Date February 5, 2019
Actual Study Start Date April 29, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2019)
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.
Original Primary Outcome Measures
 (submitted: April 10, 2018)
Standard Usability Likert Scale score [ 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
Change History Complete list of historical versions of study NCT03500757 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: April 10, 2018)
Distance from percutaneous access to target location [ Time Frame: 1 day ]
The reported distance from percutaneous access to target location, after aligning the interventional instrument.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intra-procedural 360-degree Display for Performing Percutaneous Liver Tumor Ablation
Official Title Intra-procedural 360-degree Display for Performing Percutaneous Liver Tumor Ablation as an Adjunct to Standard Flat Panel Display
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Percutaneous Tumor Ablation
Intervention Device: HoloLens
use the HoloLens to evaluate new 3D holographic guidance and navigation for percutaneous ablation of solid tumors
Other Name: headset
Study Groups/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
Intervention: Device: HoloLens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: April 10, 2018)
5
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03500757
Other Study ID Numbers CASE1218
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Case Comprehensive Cancer Center
Study Sponsor Case Comprehensive Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Charles Martin III, MD Cleveland Clinic, Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date February 2019