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

21 de julho de 2026 atualizado por: National Taiwan University Hospital

Application of Extended Reality (XR)-Assisted 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Dispositivo: NTU OpVerse surgical simulation platform

Tipo de estudo

Observacional

Inscrição (Estimado)

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Chiu Hao Hsu
Número de telefone: 73234 88623123456
E-mail: newmanhsu0814@gmail.com

Locais de estudo

Taiwan
- - Taipei, Taiwan
    - Recrutamento
    - National Taiwan University Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Accuracy of XR-Assisted Superficial Temporal Artery Localization Prazo: 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.	During preoperative surgical planning and intraoperative confirmation on the day of surgery.
Accuracy of XR-Assisted Middle Cerebral Artery Recipient-Vessel Prediction Prazo: 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.	From preoperative surgical planning to intraoperative selection of the recipient vessel on the day of surgery.

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
XR-Assisted STA Localization Time Prazo: 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.	During preoperative preparation on the day of surgery.
Time From Skin Incision to Identification of the Recipient Vessel Prazo: 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.	During the surgical procedure on the day of surgery.
Total Operative Time Prazo: 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.	During the surgical procedure on the day of surgery.
Skin-Incision Length Prazo: 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.	At completion of skin closure on the day of surgery.
Maximum Craniotomy Diameter Prazo: During the surgical procedure on the day of surgery.	The maximum diameter of the completed craniotomy will be measured in centimeters intraoperatively.	During the surgical procedure on the day of surgery.
Intraoperative Enlargement of the Planned Craniotomy Prazo: 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.	During the surgical procedure on the day of surgery.
Intraoperative Bypass Blood Flow Prazo: 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.	Immediately after completion of the bypass anastomosis on the day of surgery.
Postoperative Ischemic Complications Prazo: 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.	From completion of surgery through 30 days after surgery.
Postoperative Hemorrhagic Complications Prazo: 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	From completion of surgery through 30 days after surgery.
Change in Modified Rankin Scale Score Prazo: 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.	From baseline before surgery to 30 days after surgery.
Length of Intensive Care Unit Stay Prazo: 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.	From completion of surgery through discharge from the intensive care unit, up to 30 days after surgery.
Total Length of Hospital Stay Prazo: 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.	From the date of surgery through hospital discharge, up to 30 days after surgery.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Taiwan University Hospital

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

26 de junho de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2028

Conclusão do estudo (Estimado)

31 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

14 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ