Clinical Trial for the Validation of AR Based Neuronavigation System

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05776706

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brain Neoplasms Cerebral Aneurysm Cerebral Arteriovenous Malformation Navigation, Spatial	Diagnostic Test: AR-based navigation	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Patients who undergo craniotomy using navigation system for cerebral disease in a single institutionPatients who undergo craniotomy using navigation system for cerebral disease in a single institution

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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: Fiducial markers Nasion Tumor's margin (anterior, posterior, superior, inferior)	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. Fiducial markers Nasion Tumor's margin (anterior, posterior, superior, inferior)

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

The degree of 3-dimensional error at each measurement points (mm) [6 hours]
Fiducial markers, nasion
The degree of 3-dimensional error at each measurement points (mm) after durotomy [6 hours]
Tumor's margin, ICA bifurcation, et al.

Secondary Outcome Measures

Non-inferiority of AR-based navigation compared to conventional navigation [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.
Time required to set up and use each navigation [6 hours]
Time required to match conventional navigation and AR navigation, respectively.
Economic analysis for each navigation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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