Clinical Trial for the Validation of AR Based Neuronavigation System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AR-based navigation.
- Who it may be relevant to
- Registry conditions: Brain Neoplasms, Cerebral Aneurysm, Cerebral Arteriovenous Malformation, Navigation, Spatial. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Trial for the Evaluation of the Accuracy of Augmented Reality Based Neuronavigation System
Overview
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.
Detailed description
Being developed AR navigation were reported in our following papers:
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.
Interventions
- Diagnostic test 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)
Primary outcome measures
- The degree of 3-dimensional error at each measurement points (mm) [Time frame: 6 hours]
- The degree of 3-dimensional error at each measurement points (mm) after durotomy [Time frame: 6 hours]
Secondary outcome measures (3)
- Non-inferiority of AR-based navigation compared to conventional navigation [Time frame: 12 months]
- Time required to set up and use each navigation [Time frame: 6 hours]
- Economic analysis for each navigation [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Adult patients aged 18 years or older who underwent MRI or CT scan due to brain tumor or cerebrovascular disease
- Adult patients aged 18 years or older who need surgical treatment using navigation for brain tumor or cerebrovascular disease
Exclusion criteria
- Cases where application of navigation is not necessary according to the judgment of the researcher or surgeon
- When the patient or guardian does not agree
- Patients with anatomical deformation due to previous surgery or requiring emergency surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT05776706 · SNUH-AR001