- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07711457
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Chiu Hao Hsu
- Phone Number: 73234 88623123456
- Email: newmanhsu0814@gmail.com
Study Locations
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-
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Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The precision of surgical planning
Time Frame: During the operation
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During the operation
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202605074RINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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