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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05063773
Acronym
MRCCL
Enrollment
150
Registered
2021-10-01
Start date
2023-03-31
Completion date
2024-03-31
Last updated
2021-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Injuries

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.

Interventions

DEVICEMixed reality heads up display

Physician will use a mixed reality headset for image guidance of the procedure

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Minnesota
CollaboratorOTHER
SG Devices LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

randomized controlled

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* undergoing diagnostic coronary angiography

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Radiation exposure to the physicianup to 24 months

Secondary

MeasureTime frame
radiation exposure to the patient and medical staffup to 24 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026