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
About this trial
This is an interventional prevention trial for Radiation Injuries
Eligibility Criteria
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
NCT ID
NCT05063773
First Posted
September 8, 2021
Last Updated
September 21, 2021
Sponsor
SG Devices LLC
Collaborators
National Institutes of Health (NIH), University of Minnesota
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
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