NCT05776706

Clinical Trial for the Validation of AR Based Neuronavigation System

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Brain Neoplasms
• Cerebral Aneurysm
• Cerebral Arteriovenous Malformation
• Navigation, Spatial

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-03-20
• Last updated: 2024-12-03

Locations

1 site across 1 country: South Korea