Percutaneous Coronary InterventionNCT05377866
Holo CTO Proctoring Study
An observational study of Percutaneous Coronary Intervention and Chronic Total Occlusion of Coronary Artery, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Chronic Total Occlusion of Coronary Artery
- What is being tested?
- Remote proctoring using HoloLens
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- 4 Nov 2021to 31 Jan 2023
- Phase
- Observational
- 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
Study population: Patients with coronary artery disease and total chronic occlusion of one or more coronary arteries.
Who may be able to join
- Clinical inclusion criteria:
- Stable angina pectoris, or dyspnoea as an angina equivalent
- Age ≥18 yrs.
- Able to provide written informed consent
- Angiographic inclusion criteria:
- One or more completely occluded coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow 0. An estimated occlusion duration of at least 3 months
Show all 9Show fewer
- Absence of Q-wave in ECG leads corresponding to the occluded vessel, or documented viability of the main territory by MRI or echocardiography
- Procedural inclusion criteria:
- Clinical indication for CTO PCI regardless of operative technique
Who cannot join
- STEMI within 72 hours
- Cardiogenic shock
- Active bleeding or coagulopathy
- Life expectancy < 2 years
- Relevant allergies (aspirin, clopidrogrel, ticagrelol, contrast compounds)
- Severe peripheral artery disease
- Clinical unstable angina
Trial locations and contacts
1 site in 1 country.
About this study
Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures
Read the detailed description
Proctoring in medicine is related to better outcomes. Specifically, in CTO PCI systematic proctoring has demonstrated improved success rates, and an increased ability to treat lesions that are more complex. Most likely, proctoring together with operator volume is one of the foundations to the introduction and execution of CTO procedures. Proctoring traditionally involves an expert operator (proctor), visiting the institution, performing the procedure together with the local operator. This involves increased cost, and current travel restrictions makes traditional one-on-one proctoring challenging.
This study aims to evaluate the Microsoft HoloLens as a potential platform in proctoring and effective real time communication between PCI operators located at different geographical locations. The proctor and the local operator interact using a head mounted mixed reality (MR) display, enabling the proctor to see the same image as the operator, from any distanced location.
- Being tested
- Remote proctoring using HoloLens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote proctoring using HoloLensOther
Also called Chronic total occlusion percutaneus coronary intervention
Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Patients undergoing percutaneus coronary intervention for chronic total occlusion. The procedures will all be done using mixed reality to enable remote proctoring. The study is a feasibility trial. Receives: Other: Remote proctoring using HoloLens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Usability Score on a Likert Scale
The operators completing the intervention will rate the usability of the system on a Likert scale:
- The HoloLens was useful in this procedure
- The HoloLens was not distracting
- The HoloLens was comfortable to wear
- The HoloLens camera image has sufficient quality for clinical use (not considering the fluoroscopy screen)
- Compared to an alternative system with fluoroscopy image plus handsfree voice (telephone), the HoloLens gives additional value during the procedure
- The current solution with Remote Assist plus parallel fluoroscopy streaming is mature enough for routine use
- The current solution is stable
- The current solution is easy to set up prior to the procedure
- I would like to continue to use the HoloLens in CTO procedures routinely when remote proctoring is needed
Agree to Disagree Likert Scale
- Strongly Disagree
- Disagree
- Neither agree nor disagree
- Agree
- Strongly Agree
Measured: Procedure duration( aprox 120 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start4 Nov 2021
- Primary completion31 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital, HoloCare AS
- Responsible party
- Sponsor
- Investigators
- Slobodan Calic, MD, Principal investigator, Sorlandet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377866
- Sponsor's protocol ID
- HoloCTO
- Status last verified
- Sep 2021
- First submitted
- 27 Sep 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holo CTO Proctoring Study
- ClinicalTrials.gov ID
- NCT05377866
- Acronym / sponsor ID
- HoloCTO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Oslo University Hospital, HoloCare AS
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 17 May 2022 (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.
Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures
Detailed description
Proctoring in medicine is related to better outcomes. Specifically, in CTO PCI systematic proctoring has demonstrated improved success rates, and an increased ability to treat lesions that are more complex. Most likely, proctoring together with operator volume is one of the foundations to the introduction and execution of CTO procedures. Proctoring traditionally involves an expert operator (proctor), visiting the institution, performing the procedure together with the local operator. This involves increased cost, and current travel restrictions makes traditional one-on-one proctoring challenging.
This study aims to evaluate the Microsoft HoloLens as a potential platform in proctoring and effective real time communication between PCI operators located at different geographical locations. The proctor and the local operator interact using a head mounted mixed reality (MR) display, enabling the proctor to see the same image as the operator, from any distanced location.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Other: Remote proctoring using HoloLensPatients undergoing percutaneus coronary intervention for chronic total occlusion. The procedures will all be done using mixed reality to enable remote proctoring. The study is a feasibility trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease and total chronic occlusion of one or more coronary arteries.
Key inclusion criteria (9 listed)
- Stable angina pectoris, or dyspnoea as an angina equivalent
- Age ≥18 yrs.
- Able to provide written informed consent
- One or more completely occluded coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow 0. An estimated occlusion duration of at least 3 months
- Absence of Q-wave in ECG leads corresponding to the occluded vessel, or documented viability of the main territory by MRI or echocardiography
Key exclusion criteria (7 listed)
- STEMI within 72 hours
- Cardiogenic shock
- Active bleeding or coagulopathy
- Life expectancy < 2 years
- Relevant allergies (aspirin, clopidrogrel, ticagrelol, contrast compounds)
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 |
|---|---|---|
| Remote proctoring using HoloLensAlso: Chronic total occlusion percutaneus coronary interventionAssess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures. | Other | Study population |
Primary outcome
Standard Usability Score on a Likert Scale
Time frame: Procedure duration( aprox 120 min)
The operators completing the intervention will rate the usability of the system on a Likert scale: 1. The HoloLens was useful in this procedure 2. The HoloLens was not distracting 3. The HoloLens was comfortable to wear 4. The HoloLens camera image has sufficient quality for clinical use (not considering the fluoroscopy screen) 5. Compared to an alternative system with fluoroscopy image plus handsfree voice (telephone), the HoloLens gives additional value during the procedure 6. The current solution with Remote Assist plus parallel fluoroscopy streaming is mature enough for routine use 7. The current solution is stable 8. The current solution is easy to set up prior to the procedure 9. I would like to continue to use the HoloLens in CTO procedures routinely when remote proctoring is needed Agree to Disagree Likert Scale * Strongly Disagree * Disagree * Neither agree nor disagree * Agree * Strongly Agree
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- 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.
Slobodan Calic, MD principal investigator
Sorlandet Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Coronary Intervention and Chronic Total Occlusion of Coronary Artery, run by Sorlandet Hospital HF at 1 site in Norway.
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 9 inclusion and 7 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: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Standard Usability Score on a Likert Scale (time frame: Procedure duration( aprox 120 min)). 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 Feb 2023.