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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05063773
Other study ID # HUD_002
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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