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

NCT07711457 | Recruiting

• 1 other identifier: 202605074RINB
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Cerebral Ischemia; Moyamoya Disease; Bypass Surgery; Augmented Reality; Extended Reality (XR)

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (12)

• XR-Assisted STA Localization Time

  During preoperative preparation on the day of surgery.

• Time From Skin Incision to Identification of the Recipient Vessel

  During the surgical procedure on the day of surgery.

• Total Operative Time

  During the surgical procedure on the day of surgery.

• Skin-Incision Length

  At completion of skin closure on the day of surgery.

• Maximum Craniotomy Diameter

  During the surgical procedure on the day of surgery.

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (2)

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Moyamoya Disease

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Chiu Hao Hsu

CONTACT

88623123456; newmanhsu0814@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-06

Locations

TW (1)