Clinical Trial for the Validation of AR Based Neuronavigation System

  • End date
    Dec 31, 2026
  • participants needed
  • sponsor
    Seoul National University Hospital
Updated on 7 April 2023


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:

  1. Dho YS, et al., Development of an inside-out augmented reality technique for neurosurgical navigation. Neurosurgical Focus. 2021 Aug 1;51(2):E21. (
  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. (

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.

Condition Brain Neoplasms, Cerebral Aneurysm, Cerebral Arteriovenous Malformation, Navigation, Spatial
Treatment AR-based navigation
Clinical Study IdentifierNCT05776706
SponsorSeoul National University Hospital
Last Modified on7 April 2023


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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