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NCT Number: NCT07711457

Application of Extended Reality (XR)-Assisted Computed Tomography (CT)-Guided Localization in Extracranial-intracranial (EC-IC) Bypass Surgery

This study will evaluate the application of a metaverse-based surgical simulation platform in extracranial-intracranial (EC-IC) bypass surgery. The study population will include patients with moyamoya disease or chronic cerebral ischemia who are scheduled to undergo EC-IC bypass surgery.

Before surgery, preoperative brain computed tomography images will be imported into the metaverse surgical simulation platform. During surgery, extended reality technology will be used to provide precise localization of the relevant vessels, including both the donor and recipient arteries.

The primary objective is to assess the localization accuracy of this platform. The study will also investigate whether this technology can facilitate a minimally invasive surgical approach and improve surgical safety.

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Key information

Conditions

Chronic Cerebral Ischemia Arterial Occlusive Diseases Augmented Reality Brain Diseases Bypass Surgery Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebrovascular Disorders Extended Reality (XR) Intracranial Arterial Diseases Moyamoya Disease Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients diagnosed with ischemic moyamoya disease, moyamoya syndrome, or chronic intracranial internal carotid artery stenosis or occlusion (chronic ICA stenosis/occlusion).
  • Patients scheduled to undergo extracranial-intracranial bypass surgery (EC-IC bypass), including superficial temporal artery-middle cerebral artery bypass (STA-MCA bypass), superficial temporal artery trunk-interposition graft-middle cerebral artery bypass (STA trunk-graft-MCA bypass), or other cerebral revascularization procedures using the superficial temporal artery or another branch of the external carotid artery system (STA/ECA system) as the donor blood supply.

Exclusion criteria

  • Presence of a contraindication to computed tomography (CT) scanning.
  • Presence of a severe systemic illness that would prevent participation in subsequent study assessments, such as poorly controlled diabetes mellitus, active malignancy, or severe cardiac disease.
  • The need for emergency surgery without sufficient time to complete image-based modeling and registration.
  • Presence of scalp lesions, wounds, or anatomical deformities that prevent reliable surface registration.
  • The XR registration result is considered unreliable by the research team and may potentially compromise surgical safety.

Treatment and study plan

NTU OpVerse surgical simulation platform

Device

NTU OpVerse is a patient-specific metaverse-based surgical simulation and assistance platform developed through collaboration among National Taiwan University Hospital, National Taiwan University, and technology partners. The platform integrates medical-image processing, three-dimensional reconstruction, digital-twin technology, and extended reality, including virtual, augmented, and mixed-reality applications.

Patient-specific computed tomography or magnetic resonance imaging data can be imported into the platform and reconstructed into interactive three-dimensional anatomical models. These models allow surgeons to visualize the spatial relationships among target lesions, blood vessels, organs, bones, and other relevant anatomical structures. Through an immersive extended-reality interface, surgeons can manipulate the reconstructed models, examine them from different perspectives, and conduct individualized preoperative planning and procedural simulation.

Primary outcomes

  1. Accuracy of XR-Assisted Superficial Temporal Artery Localization

    Time frame: During preoperative surgical planning and intraoperative confirmation on the day of surgery.

    Accuracy will be assessed as the absolute distance, measured in millimeters, between the superficial temporal artery location marked using the XR-assisted surgical planning system and the actual superficial temporal artery location identified by vascular ultrasonography. The mean absolute distance error across participants will be reported.

  2. Accuracy of XR-Assisted Middle Cerebral Artery Recipient-Vessel Prediction

    Time frame: From preoperative surgical planning to intraoperative selection of the recipient vessel on the day of surgery.

    Accuracy will be assessed as the absolute distance, measured in millimeters, between the anastomosis site predicted using the XR-assisted surgical planning system and the actual recipient-vessel anastomosis site selected intraoperatively. The mean absolute distance error across participants will be reported.

Secondary outcomes

  1. XR-Assisted STA Localization Time

    Time frame: During preoperative preparation on the day of surgery.

    The time required to localize and mark the superficial temporal artery and middle cerebral artery using the XR-assisted system will be measured in minutes, from initiation of XR registration and localization to completion of skin marking.

  2. Time From Skin Incision to Identification of the Recipient Vessel

    Time frame: During the surgical procedure on the day of surgery.

    The time from the initial skin incision to intraoperative identification of the middle cerebral artery recipient vessel selected for bypass will be measured in minutes.

  3. Total Operative Time

    Time frame: During the surgical procedure on the day of surgery.

    Total operative time will be measured in minutes, from the initial skin incision to completion of skin closure.

  4. Skin-Incision Length

    Time frame: At completion of skin closure on the day of surgery.

    The length of the final skin incision will be measured in centimeters after completion of the surgical procedure.

  5. Maximum Craniotomy Diameter

    Time frame: During the surgical procedure on the day of surgery.

    The maximum diameter of the completed craniotomy will be measured in centimeters intraoperatively.

  6. Intraoperative Enlargement of the Planned Craniotomy

    Time frame: During the surgical procedure on the day of surgery.

    The number and percentage of participants requiring intraoperative enlargement of the craniotomy beyond the preoperatively planned dimensions will be reported.

  7. Intraoperative Bypass Blood Flow

    Time frame: Immediately after completion of the bypass anastomosis on the day of surgery.

    Blood flow through the completed bypass will be measured in milliliters per minute using an intraoperative flow-measurement device after completion of the anastomosis.

  8. Postoperative Ischemic Complications

    Time frame: From completion of surgery through 30 days after surgery.

    The number and percentage of participants experiencing a new postoperative cerebral ischemic event, including transient ischemic attack or ischemic stroke, will be reported. Events will be determined by neurological assessment and clinically indicated neuroimaging.

  9. Postoperative Hemorrhagic Complications

    Time frame: From completion of surgery through 30 days after surgery.

    The number and percentage of participants experiencing a new postoperative intracranial hemorrhagic complication will be reported. Events will be determined by neurological assessment and postoperative neuroimaging

  10. Change in Modified Rankin Scale Score

    Time frame: From baseline before surgery to 30 days after surgery.

    The change in modified Rankin Scale score will be calculated as the postoperative score minus the preoperative baseline score. The modified Rankin Scale ranges from 0 to 6, with higher scores indicating greater disability.

  11. Length of Intensive Care Unit Stay

    Time frame: From completion of surgery through discharge from the intensive care unit, up to 30 days after surgery.

    The duration of postoperative intensive care unit stay will be measured in days, from admission to the intensive care unit after surgery to transfer out of the intensive care unit.

  12. Total Length of Hospital Stay

    Time frame: From the date of surgery through hospital discharge, up to 30 days after surgery.

    The total postoperative hospital stay will be measured in days, from the date of surgery to the date of hospital discharge.

Study contacts

Contact information is provided by the study sponsor or research team.

Chiu Hao Hsu

CONTACT

[email protected]

88623123456 ext. 73234

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Application of Extended Reality (XR)-Assisted CT-Guided Localization in Extracranial-intracranial (EC-IC) Bypass Surgery

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 17, 2026
Registry last updated
Jul 23, 2026

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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