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

21. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Odhadovaný)

30

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Tchaj-wan
      • Taipei, Tchaj-wan
        • Nábor
        • National Taiwan University Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Accuracy of XR-Assisted Superficial Temporal Artery Localization
Časové okno: 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
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
XR-Assisted STA Localization Time
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

National Taiwan University Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

26. června 2026

Primární dokončení (Odhadovaný)

31. prosince 2028

Dokončení studie (Odhadovaný)

31. prosince 2028

Termíny zápisu do studia

První předloženo

14. července 2026

První předloženo, které splnilo kritéria kontroly kvality

14. července 2026

První zveřejněno (Aktuální)

17. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

23. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. července 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 202605074RINB

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Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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