Novel Wireless Mixed Reality Headset for Image Guidance i... | NCT05063773

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

NCT05063773

Sponsor

SG Devices LLC

Status

Unknown status

Last Update Posted

Oct 1, 2021Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Radiation Injuries

Interventions

Mixed reality heads up display

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2023Estimated

Primary Completion Date

Mar 2024Estimated

Completion Date

Mar 2024Estimated

First Submitted Date

Sep 8, 2021

First Submission Date that Met QC Criteria

Sep 21, 2021

First Posted Date

Oct 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2021

Last Update Posted Date

Oct 1, 2021Actual

Name	Class
National Institutes of Health (NIH)	NIH
University of Minnesota	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental		Device: Mixed reality heads up display
Group 2	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mixed reality heads up display	Device	Physician will use a mixed reality headset for image guidance of the procedure	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiation exposure to the physician		up to 24 months

Secondary Outcomes

Measure	Description	Time Frame
radiation exposure to the patient and medical staff		up to 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

undergoing diagnostic coronary angiography

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011832	Radiation Injuries

Ancestor Terms

ID	Term
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided