NCT05063773

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

September 8, 2021

Last Update Submit

September 21, 2021

Conditions

Radiation Injuries

Outcome Measures

Primary Outcomes (1)

  • Radiation exposure to the physician

    up to 24 months

Secondary Outcomes (1)

  • radiation exposure to the patient and medical staff

    up to 24 months

Study Arms (2)

Group 1

EXPERIMENTAL
Device: Mixed reality heads up display

Group 2

NO INTERVENTION

Interventions

Mixed reality heads up displayDEVICE

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

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing diagnostic coronary angiography

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

October 1, 2021

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share