Clinical Trial for the Validation of AR Based Neuronavigation System

Clinical Trial for the Evaluation of the Accuracy of Augmented Reality 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.

Study Overview

• Status: Recruiting
• Conditions: Brain Neoplasms; Cerebral Aneurysm; Cerebral Arteriovenous Malformation; Navigation, Spatial
• Intervention / Treatment: Diagnostic test: AR-based navigation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chul-Kee Park, MD, PhD; Phone Number: +82220720347; Email: nsckpark@snu.ac.kr
• Study Contact Backup: Name: Ho Kang, MD; Phone Number: +821085571217; Email: kang.ho85@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Chul-Kee Park, MD, PhD; Phone Number: +82220720347; Email: nsckpark@snu.ac.kr
    • Contact: Ho Kang, MD; Phone Number: +821085571217; Email: kang.ho85@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time required to set up and use each navigation	Time required to match conventional navigation and AR navigation, respectively.	6 hours
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Chul-Kee Park, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: augmented reality; cerebral aneurysm; neuronavigation; brain neoplasms; cerebral arteriovenous malformation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Cardiovascular Abnormalities; Nervous System Malformations; Vascular Malformations; Intracranial Arterial Diseases; Central Nervous System Vascular Malformations; Congenital Abnormalities; Brain Neoplasms; Arteriovenous Malformations; Aneurysm; Intracranial Aneurysm; Intracranial Arteriovenous Malformations
• Other Study ID Numbers: SNUH-AR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No