Clinical trial · Interventional
Clinical Trial for the Validation of AR Based Neuronavigation System
Clinical Trial for the Evaluation of the Accuracy of Augmented Reality Based Neuronavigation System
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Cerebral Aneurysm | — | UNRESOLVED | — |
| Cerebral Arteriovenous Malformation | — | UNRESOLVED | — |
| Navigation, Spatial | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AR-based navigation | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- 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)
- interventionNames
- Diagnostic Test: AR-based navigation
Primary outcomes (2)
- measure
- The degree of 3-dimensional error at each measurement points (mm)
- timeFrame
- 6 hours
- description
- Fiducial markers, nasion
- measure
- The degree of 3-dimensional error at each measurement points (mm) after durotomy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available