Radiation InjuriesMRCCLNCT05063773
Novel Wireless Mixed Reality Headset for Image Guidance in Cardiac Catheterization Laboratory
A study testing Mixed reality heads up display in people with Radiation Injuries, run by SG Devices LLC.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Injuries
- What is being tested?
- Mixed reality heads up display
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing diagnostic coronary angiography
Who cannot join
- acute coronary syndrome, cardiogenic shock, cardiac arrest, planned intervention
About this study
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
- Being tested
- Mixed reality heads up display
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed reality heads up displayDevice
Physician will use a mixed reality headset for image guidance of the procedure
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Device: Mixed reality heads up display |
| Group 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation exposure to the physician
Measured: up to 24 months
Secondary outcomes (1)
radiation exposure to the patient and medical staff
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study startMar 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SG Devices LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063773
- Sponsor's protocol ID
- HUD_002
- Acronym
- MRCCL
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Wireless Mixed Reality Headset for Image Guidance in Cardiac Catheterization Laboratory
- ClinicalTrials.gov ID
- NCT05063773
- Acronym / sponsor ID
- MRCCL / HUD_002
- Conditions
- Radiation Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- SG Devices LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), University of Minnesota
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Mixed reality heads up display |
| Group 2 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing diagnostic coronary angiography
Key exclusion criteria (1 listed)
- acute coronary syndrome, cardiogenic shock, cardiac arrest, planned intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed reality heads up displayPhysician will use a mixed reality headset for image guidance of the procedure | Device | Group 1 |
Primary outcome
Radiation exposure to the physician
Time frame: up to 24 months
1 secondary outcome
radiation exposure to the patient and medical staff
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed reality heads up display in people with Radiation Injuries, run by SG Devices LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation exposure to the physician (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.