Clinical Trial for the Validation of AR Based Neuronavigation System

Trial Title: Clinical Trial for the Validation of AR Based Neuronavigation System

NCT ID: NCT05776706

Condition: Brain Neoplasms
Cerebral Aneurysm
Cerebral Arteriovenous Malformation
Navigation, Spatial

Conditions: Official terms:
Brain Neoplasms
Intracranial Aneurysm
Intracranial Arteriovenous Malformations
Aneurysm
Arteriovenous Malformations
Congenital Abnormalities

Conditions: Keywords:
augmented reality
neuronavigation
brain neoplasms
cerebral arteriovenous malformation
cerebral aneurysm

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Patients who undergo craniotomy using navigation system for cerebral disease in a single institution

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: AR-based navigation
Description: 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)
Arm group label: Single arm

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: No

Locations:

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Ho Kang, MD

Phone: +821085571217
Email: kang.ho85@gmail.com

Contact backup:
Last name: Chul-Kee Park, MD, PhD

Phone: +82220720347
Email: nsckpark@snu.ac.kr

Start date: June 1, 2023

Completion date: December 31, 2026

Lead sponsor:
Agency: Seoul National University Hospital
Agency class: Other

Source: Seoul National University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05776706