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

21 de julio de 2026 actualizado 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Estimado)

30

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Taiwán
      • Taipei, Taiwán
        • Reclutamiento
        • National Taiwan University Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

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¿Cómo está diseñado el estudio?

Detalles de diseño

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Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Accuracy of XR-Assisted Superficial Temporal Artery Localization
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
XR-Assisted STA Localization Time
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

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Patrocinador

National Taiwan University Hospital

Publicaciones y enlaces útiles

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Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

26 de junio de 2026

Finalización primaria (Estimado)

31 de diciembre de 2028

Finalización del estudio (Estimado)

31 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

14 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de julio de 2026

Publicado por primera vez (Actual)

17 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de julio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 202605074RINB

Plan de datos de participantes individuales (IPD)

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INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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