Clinical Trial for the Validation of AR Based Neuronavigation System
NCT ID: NCT05776706
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2025-05-01
2027-12-31
Brief Summary
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• 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.
Detailed Description
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1. Dho YS, et al., Development of an inside-out augmented reality technique for neurosurgical navigation. Neurosurgical Focus. 2021 Aug 1;51(2):E21. (doi.org/10.3171/2021.5.FOCUS21184)
2. Moon HC, et al., Navigation of frameless fixation for gamma knife radiosurgery using fixed augmented reality. Scientific Reports. 2022 Mar 16;12(1):1-0. (doi.org/10.3171/2021.5.FOCUS21184)
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Single arm
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:
1. Fiducial markers
2. Nasion
3. Tumor's margin (anterior, posterior, superior, inferior)
AR-based navigation
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.
1. Fiducial markers
2. Nasion
3. Tumor's margin (anterior, posterior, superior, inferior)
Interventions
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AR-based navigation
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.
1. Fiducial markers
2. Nasion
3. Tumor's margin (anterior, posterior, superior, inferior)
Eligibility Criteria
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Inclusion Criteria
* Adult patients aged 18 years or older who need surgical treatment using navigation for brain tumor or cerebrovascular disease
Exclusion Criteria
* When the patient or guardian does not agree
* Patients with anatomical deformation due to previous surgery or requiring emergency surgery
18 Years
85 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Chul-Kee Park
Professor
Principal Investigators
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Chul-Kee Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SNUH-AR001
Identifier Type: -
Identifier Source: org_study_id