Clinical trial NCT05776706: Clinical Trial for the Validation of AR Based Neuronavigation System
Official title: Clinical Trial for the Evaluation of the Accuracy of Augmented Reality Based Neuronavigation System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Neoplasms
Cerebral Aneurysm
Cerebral Arteriovenous Malformation
Navigation, Spatial
Keywords: augmented reality
neuronavigation
brain neoplasms
cerebral arteriovenous malformation
cerebral aneurysm
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients who undergo craniotomy using navigation system for cerebral disease in a single institution
Primary purpose: OTHER

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.

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.

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

Primary outcomes:
measure: The degree of 3-dimensional error at each measurement points (mm)
timeFrame: 6 hours
measure: The degree of 3-dimensional error at each measurement points (mm) after durotomy
timeFrame: 6 hours
Secondary outcomes:
measure: Non-inferiority of AR-based navigation compared to conventional navigation
timeFrame: 12 months
measure: Time required to set up and use each navigation
timeFrame: 6 hours
measure: Economic analysis for each navigation
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chul-Kee Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: