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

Official title

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

Overview

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.

Interventions

• Device NTU OpVerse surgical simulation platform
  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 impor

Primary outcome measures

• Accuracy of XR-Assisted Superficial Temporal Artery Localization [Time frame: During preoperative surgical planning and intraoperative confirmation on the day of surgery.]
• 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.]

Secondary outcome measures (12)

• XR-Assisted STA Localization Time [Time frame: During preoperative preparation on the day of surgery.]
• Time From Skin Incision to Identification of the Recipient Vessel [Time frame: During the surgical procedure on the day of surgery.]
• Total Operative Time [Time frame: During the surgical procedure on the day of surgery.]
• Skin-Incision Length [Time frame: At completion of skin closure on the day of surgery.]
• Maximum Craniotomy Diameter [Time frame: During the surgical procedure on the day of surgery.]
• Intraoperative Enlargement of the Planned Craniotomy [Time frame: During the surgical procedure on the day of surgery.]
• Intraoperative Bypass Blood Flow [Time frame: Immediately after completion of the bypass anastomosis on the day of surgery.]
• Postoperative Ischemic Complications [Time frame: From completion of surgery through 30 days after surgery.]
• Postoperative Hemorrhagic Complications [Time frame: From completion of surgery through 30 days after surgery.]
• Change in Modified Rankin Scale Score [Time frame: From baseline before surgery to 30 days after surgery.]
• 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.]
• Total Length of Hospital Stay [Time frame: From the date of surgery through hospital discharge, up to 30 days after surgery.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Taiwan · 1 center

• National Taiwan University Hospital — Taipei

Publications

• Saemann A, de Wilde D, Guzman R, Soleman J, Greuter L. Augmented and Virtual Reality in Open Neurovascular Surgery: A Systematic Review of the Literature. World Neurosurg. 2026 Jan;205:124632. doi: 10.1016/j.wneu.2025.124632. Epub 2025 Nov 6. PMID 41205868
• Bhatia S, Huynh A, Shanahan RM, Kann MR, Gopakumar A, Sharma N, Kass NM, Hurt G, Basdeo R, Don N, Lang MJ, Biehl JT, Andrews EG. Optimizing the Workflow of Superficial Temporal Artery Mapping in Extracranial-Intracranial Bypass Surgery Using Mixed Reality: A Proof-of-Concept Study. World Neurosurg. 2025 Dec;204:124562. doi: 10.1016/j.wneu.2025.124562. Epub 2025 Oct 13. PMID 41093253

Identifiers

NCT: NCT07711457 · 202605074RINB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗