Clinical Trial for the Validation of AR Based Neuronavigation System

NCT05776706 | Not Yet Recruiting

• 1 other identifier: SNUH-AR001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Neoplasms; Cerebral Aneurysm; Cerebral Arteriovenous Malformation; Navigation, Spatial

Keywords

augmented reality; neuronavigation; brain neoplasms; cerebral arteriovenous malformation; cerebral aneurysm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Non-inferiority of AR-based navigation compared to conventional navigation

  12 months

• Time required to set up and use each navigation

  6 hours

• Economic analysis for each navigation

  12 months

Study Arms (1)

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)

Diagnostic Test: AR-based navigation

Interventions

AR-based navigation DIAGNOSTIC_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. 1. Fiducial markers 2. Nasion 3. Tumor's margin (anterior, posterior, superior, inferior)

Single arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Brain Neoplasms; Intracranial Aneurysm; Intracranial Arteriovenous Malformations; Spatial Navigation

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spatial Behavior; Behavior

Study Officials

• Chul-Kee Park, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho Kang, MD

CONTACT

+821085571217; kang.ho85@gmail.com

Chul-Kee Park, MD, PhD

CONTACT

+82220720347; nsckpark@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients who undergo craniotomy using navigation system for cerebral disease in a single institution

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: March 20, 2023
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)