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NCT Number: NCT05776706

Clinical Trial for the Validation of AR Based Neuronavigation System

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.

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Key information

Conditions

Brain Neoplasms Aneurysm Arteriovenous Malformations Behavior Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Central Nervous System Vascular Malformations Cerebral Aneurysm Cerebral Arteriovenous Malformation Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Intracranial Aneurysm Intracranial Arterial Diseases Intracranial Arteriovenous Malformations Navigation, Spatial Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Malformations Nervous System Neoplasms Spatial Behavior Spatial Navigation Vascular Diseases Vascular Malformations

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Being developed AR navigation were reported in our following papers:

  • 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)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

  • Fiducial markers
  • Nasion
  • Tumor's margin (anterior, posterior, superior, inferior)

Primary outcomes

  1. The degree of 3-dimensional error at each measurement points (mm)

    Time frame: 6 hours

    Fiducial markers, nasion

  2. The degree of 3-dimensional error at each measurement points (mm) after durotomy

    Time frame: 6 hours

    Tumor's margin, ICA bifurcation, et al.

Secondary outcomes

  1. Non-inferiority of AR-based navigation compared to conventional navigation

    Time frame: 12 months

    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.

  2. Time required to set up and use each navigation

    Time frame: 6 hours

    Time required to match conventional navigation and AR navigation, respectively.

  3. Economic analysis for each navigation

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chul-Kee Park, MD, PhD

CONTACT

[email protected]

+82220720347

Ho Kang, MD

CONTACT

[email protected]

+821085571217

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Clinical Trial for the Evaluation of the Accuracy of Augmented Reality Based Neuronavigation System

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 20, 2023
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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