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The goal of this clinical trial is to test augmented reality (AR) based neuronavigation system in surgeries for patients of brain neoplasm or cerebral vascular disease. The main questions it aims to answer are:
• AR based neuronavigation system can achieve accuracy that is not inferior to conventional intraoperative navigation system.
Participants will participate the study after informed consent. When participants undergo surgery for their brain tumor, we will set up 2 types of neuronavigation, conventional navigation system and developed AR based neuronavigation system. Surgeon will plan and conduct surgery based on only conventional navigation system, but 3D errors at several selected points between two types of navigation will be measured and analyzed.
Being developed AR navigation were reported in our following papers:
This study aims to evaluate the accuracy of anatomical localization of a newly developed augmented reality-based neurosurgery navigation. After 3-dimensional (3D) modeling of the brain of a patient with brain tumor or cerebral vascular disease through 3D image segmentation extraction and modeling, the Augmented Reality (AR)-based navigation developed by this research team can be used with a commercially available visualization device, such as iPad, iPhone, and Hololens2, to evaluate the accuracy.
The AR-based navigation obtained approval from the Ministry of Food and Drug Safety of Republic of Korea (class 2 medical device) in February 2022. Through this clinical tria that compare accuracy with existing conventional intraoperative neuronavigation system, we will evaluate whether it shows equivalent performance to replace the existing navigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | We will set up 2 navigation systems, newly developed AR-based navigation and conventional navigation system, to surgeries of all participants. Surgeons will perform all surgical planning and operations with reference to the conventional navigation system. In this process, the errors of the existing navigation and the newly developed navigation will be measured and compared in 3D at several points, and the points are as follows:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR-based navigation | Diagnostic Test | The surgeon will perform all surgical planning and operations with reference to the existing navigation. In this process, the errors of the existing navigation and the newly developed navigation are measured and compared in 3D at several points, and the points are as follows.
|
| Measure | Description | Time Frame |
|---|---|---|
| The degree of 3-dimensional error at each measurement points (mm) | Fiducial markers, nasion | 6 hours |
| The degree of 3-dimensional error at each measurement points (mm) after durotomy | Tumor's margin, ICA bifurcation, et al. | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of AR-based navigation compared to conventional navigation | Statistical comparison of the average value between the error with the actual position of conventional navigation and the error with the actual position of AR navigation. | 12 months |
| Time required to set up and use each navigation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ho Kang, MD | Contact | +821085571217 | kang.ho85@gmail.com | |
| Chul-Kee Park, MD, PhD | Contact | +82220720347 | nsckpark@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Chul-Kee Park, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D002532 | Intracranial Aneurysm |
| D002538 | Intracranial Arteriovenous Malformations |
| D065854 | Spatial Navigation |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Patients who undergo craniotomy using navigation system for cerebral disease in a single institution
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|
Time required to match conventional navigation and AR navigation, respectively. |
| 6 hours |
| Economic analysis for each navigation | Economic benefits that can be expected if AR-based navigation can replace conventional navigation will be assessed. Cost for surgery, cost of whole admission period, and hospital day will be evaluated. | 12 months |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013037 | Spatial Behavior |
| D001519 | Behavior |