search
Back to results

Novel Wireless Mixed Reality Headset for Image Guidance in Cardiac Catheterization Laboratory (MRCCL)

Primary Purpose

Radiation Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mixed reality heads up display
Sponsored by
SG Devices LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Radiation Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • undergoing diagnostic coronary angiography

Exclusion Criteria:

  • acute coronary syndrome, cardiogenic shock, cardiac arrest, planned intervention

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group 1

    Group 2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Radiation exposure to the physician

    Secondary Outcome Measures

    radiation exposure to the patient and medical staff

    Full Information

    First Posted
    September 8, 2021
    Last Updated
    September 21, 2021
    Sponsor
    SG Devices LLC
    Collaborators
    National Institutes of Health (NIH), University of Minnesota
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05063773
    Brief Title
    Novel Wireless Mixed Reality Headset for Image Guidance in Cardiac Catheterization Laboratory
    Acronym
    MRCCL
    Official Title
    Novel Wireless Mixed Reality Headset for Image Guidance in Cardiac Catheterization Laboratory
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SG Devices LLC
    Collaborators
    National Institutes of Health (NIH), University of Minnesota

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Our hypothesis is that improved line of sight to patient data, ergonomics, and headset lead shielding in the CCL will lead to behavioral changes in the CCL personnel that will reduce radiation exposure to all members of the team. Further, reducing the burden of large, cumbersome monitors will enable improved use of shielding. Our approach is a single center randomized controlled trial of consecutive patients randomly assigned to one of two groups with group 1 using mixed reality display and group 2 using standard 2D displays to perform diagnostic angiography in the CCL. Radiation exposure will be evaluated at multiple levels including total radiation exposure, exposure of each individual staff member, as well as specific exposure to eyes and head in group 1 versus group 2.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Radiation Injuries

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized controlled
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Title
    Group 2
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    Mixed reality heads up display
    Intervention Description
    Physician will use a mixed reality headset for image guidance of the procedure
    Primary Outcome Measure Information:
    Title
    Radiation exposure to the physician
    Time Frame
    up to 24 months
    Secondary Outcome Measure Information:
    Title
    radiation exposure to the patient and medical staff
    Time Frame
    up to 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: undergoing diagnostic coronary angiography Exclusion Criteria: acute coronary syndrome, cardiogenic shock, cardiac arrest, planned intervention

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Novel Wireless Mixed Reality Headset for Image Guidance in Cardiac Catheterization Laboratory

    We'll reach out to this number within 24 hrs