Brain NeoplasmsNCT05776706
Clinical Trial for the Validation of AR Based Neuronavigation System
A study testing AR-based navigation in people with Brain Neoplasms and Cerebral Aneurysm, run by Seoul National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Brain Neoplasms, Cerebral Aneurysm, Cerebral Arteriovenous Malformation
- What is being tested?
- AR-based navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, 03080
Sun Mo Nam, MD, +821096713692, md.nsm.ns@gmail.com
Chul-Kee Park, MD, PhD, +82220720347, nsckpark@snu.ac.kr
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Neoplasms, Cerebral Aneurysm, Cerebral Arteriovenous Malformation, Navigation, Spatial
- Being tested
- AR-based navigation
- Keywords
- augmented reality, neuronavigation, brain neoplasms, cerebral arteriovenous malformation, cerebral aneurysm
- Medical subject headings
- Brain Neoplasms, Intracranial Aneurysm, Intracranial Arteriovenous Malformations, Spatial Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-based navigationDiagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | 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:
1. Fiducial markers
2. Nasion
3. Tumor's margin (anterior, posterior, superior, inferior) Receives: Diagnostic Test: AR-based navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of 3-dimensional error at each measurement points (mm)
Fiducial markers, nasion
Measured: 6 hours
The degree of 3-dimensional error at each measurement points (mm) after durotomy
Tumor's margin, ICA bifurcation, et al.
Measured: 6 hours
Secondary outcomes (3)
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.
Measured: 12 months
Time required to set up and use each navigation
Time required to match conventional navigation and AR navigation, respectively.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients who undergo craniotomy using navigation system for cerebral disease in a single institution
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chul-Kee Park, Seoul National University Hospital
- Investigators
- Chul-Kee Park, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776706
- Sponsor's protocol ID
- SNUH-AR001
- Status last verified
- Nov 2024
- First submitted
- 5 Dec 2022
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Evaluation of the Accuracy of Augmented Reality Based Neuronavigation System
- ClinicalTrials.gov ID
- NCT05776706
- Acronym / sponsor ID
- SNUH-AR001
- Conditions
- Brain Neoplasms, Cerebral Aneurysm, Cerebral Arteriovenous Malformation, Navigation, Spatial
- Keywords
- augmented reality, neuronavigation, brain neoplasms, cerebral arteriovenous malformation, cerebral aneurysm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients who undergo craniotomy using navigation system for cerebral disease in a single institution
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Diagnostic Test: AR-based navigationWe 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: 1. Fiducial markers 2. Nasion 3. Tumor's margin (anterior, posterior, superior, inferior) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR-based navigationThe 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) | Diagnostic test | Single arm |
Primary outcome
The degree of 3-dimensional error at each measurement points (mm)
Time frame: 6 hours
Fiducial markers, nasion
The degree of 3-dimensional error at each measurement points (mm) after durotomy
Time frame: 6 hours
Tumor's margin, ICA bifurcation, et al.
3 secondary outcomes
Non-inferiority of AR-based navigation compared to conventional navigation
Time frame: 12 months
Time required to set up and use each navigation
Time frame: 6 hours
Economic analysis for each navigation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chul-Kee Park, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR-based navigation in people with Brain Neoplasms and Cerebral Aneurysm, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ho Kang, MD (+821085571217, kang.ho85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of 3-dimensional error at each measurement points (mm) (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.