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

2026년 7월 21일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

관찰

등록 (추정된)

30

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 대만
      • Taipei, 대만
        • 모병
        • National Taiwan University Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Accuracy of XR-Assisted Superficial Temporal Artery Localization
기간: 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
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
XR-Assisted STA Localization Time
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Taiwan University Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 26일

기본 완료 (추정된)

2028년 12월 31일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 7월 14일

QC 기준을 충족하는 최초 제출

2026년 7월 14일

처음 게시됨 (실제)

2026년 7월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 21일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 202605074RINB

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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