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

Radiation Injuries Clinical Trial

— MRCCL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05063773
• Other study ID #: HUD_002
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: March 2024

Study information

• Verified date: September 2021
• Source: SG Devices LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• undergoing diagnostic coronary angiography

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Radiation Injuries

Intervention

Device:
• Mixed reality heads up display
Physician will use a mixed reality headset for image guidance of the procedure

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
SG Devices LLC	National Institutes of Health (NIH), University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation exposure to the physician		up to 24 months
Secondary	radiation exposure to the patient and medical staff		up to 24 months