Clinical Trial for the Validation of AR Based Neuronavigation System

Brain Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776706
• Other study ID #: SNUH-AR001
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2023
• Source: Seoul National University Hospital
• Contact: Ho Kang, MD
• Phone: +821085571217
• Email: kang.ho85[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Arteriovenous Malformations
• Brain Neoplasms
• Cerebral Aneurysm
• Cerebral Arteriovenous Malformation
• Congenital Abnormalities
• Intracranial Aneurysm
• Intracranial Arteriovenous Malformations
• Navigation, Spatial

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of 3-dimensional error at each measurement points (mm)	Fiducial markers, nasion	6 hours
Primary	The degree of 3-dimensional error at each measurement points (mm) after durotomy	Tumor's margin, ICA bifurcation, et al.	6 hours
Secondary	Non-inferiority of AR-based navigation compared to conventional navigation	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.	12 months
Secondary	Time required to set up and use each navigation	Time required to match conventional navigation and AR navigation, respectively.	6 hours
Secondary	Economic analysis for each navigation	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.	12 months