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Holo CTO Proctoring Study

Sponsor
Sorlandet Hospital HF (Other)
Overall Status
Recruiting
CT.gov ID
NCT05377866
Collaborator
Oslo University Hospital (Other), HoloCare AS (Other)
10
Enrollment
1
Location
14.9
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Remote proctoring using HoloLens

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

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Holo CTO Proctoring Study
Actual Study Start Date :
Nov 4, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Other: Remote proctoring using HoloLens
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Standard Usability Score on a Likert Scale [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sorlandet Hospital Arendal Agder Norway 4808

    Sponsors and Collaborators

    • Sorlandet Hospital HF
    • Oslo University Hospital
    • HoloCare AS

    Investigators

    • Principal Investigator: Slobodan Calic, MD, Sorlandet Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sorlandet Hospital HF
    ClinicalTrials.gov Identifier:
    NCT05377866
    Other Study ID Numbers:
    • HoloCTO
    First Posted:
    May 17, 2022
    Last Update Posted:
    May 17, 2022
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 17, 2022