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OpenTrials
Completed

NCT Number: NCT05377866

Holo CTO Proctoring Study

Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sorlandet Hospital

Arendal, Agder, 4808, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • 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

Exclusion criteria

  • 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

Treatment and study plan

Remote proctoring using HoloLens

Other

Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures.

Other names: Chronic total occlusion percutaneus coronary intervention

Primary outcomes

  1. 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:

    • 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

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Collaborators

  • HoloCare AS
  • Oslo University Hospital

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 17, 2022
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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