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

NCT05063773 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-10-01

No results posted yet for this study

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.

Conditions

  • Radiation Injuries

Interventions

DEVICE

Mixed reality heads up display

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Minnesota

    collaborator OTHER

  • SG Devices LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2024-03-31
Completion
2024-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05063773 on ClinicalTrials.gov