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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population will include adult patients diagnosed with ischemic moyamoya disease, moyamoya syndrome, or chronic intracranial internal carotid artery stenosis or occlusion who are scheduled to undergo extracranial-intracranial bypass surgery. Eligible procedures include STA-MCA bypass, STA trunk-graft-MCA bypass, and other cerebral revascularization procedures using the superficial temporal artery or another branch of the external carotid artery as the donor vessel. Patients requiring emergency surgery, those with contraindications to CT imaging, severe systemic illness precluding follow-up assessment, scalp conditions or anatomical deformities preventing surface registration, or unreliable XR registration that may compromise surgical safety will be excluded.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Accuracy of XR-Assisted Superficial Temporal Artery Localization

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.

Time frame
During preoperative surgical planning and intraoperative confirmation on the day of surgery.
2

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

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.

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

Secondary outcomes

1

XR-Assisted STA Localization Time

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.

Time frame
During preoperative preparation on the day of surgery.
2

Time From Skin Incision to Identification of the Recipient Vessel

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.

Time frame
During the surgical procedure on the day of surgery.
3

Total Operative Time

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

Time frame
During the surgical procedure on the day of surgery.
4

Skin-Incision Length

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.