Trials / Unknown
UnknownNCT05063773
Novel Wireless Mixed Reality Headset for Image Guidance in Cardiac Catheterization Laboratory
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- SG Devices LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Mixed reality heads up display | Physician will use a mixed reality headset for image guidance of the procedure |
Timeline
- Start date
- 2023-03-01
- Primary completion
- 2024-03-01
- Completion
- 2024-03-01
- First posted
- 2021-10-01
- Last updated
- 2021-10-01
Source: ClinicalTrials.gov record NCT05063773. Inclusion in this directory is not an endorsement.