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Clinical Trial for the Validation of AR Based Neuronavigation System

Primary Purpose

Brain Neoplasms, Cerebral Aneurysm, Cerebral Arteriovenous Malformation

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AR-based navigation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Brain Neoplasms focused on measuring augmented reality, neuronavigation, brain neoplasms, cerebral arteriovenous malformation, cerebral aneurysm

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

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: Fiducial markers Nasion Tumor's margin (anterior, posterior, superior, inferior)

Outcomes

Primary Outcome Measures

The degree of 3-dimensional error at each measurement points (mm)
Fiducial markers, nasion
The degree of 3-dimensional error at each measurement points (mm) after durotomy
Tumor's margin, ICA bifurcation, et al.

Secondary Outcome Measures

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.
Time required to set up and use each navigation
Time required to match conventional navigation and AR navigation, respectively.
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.

Full Information

First Posted
December 5, 2022
Last Updated
May 8, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05776706
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms, Cerebral Aneurysm, Cerebral Arteriovenous Malformation, Navigation, Spatial
Keywords
augmented reality, neuronavigation, brain neoplasms, cerebral arteriovenous malformation, cerebral aneurysm

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients who undergo craniotomy using navigation system for cerebral disease in a single institution
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
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: Fiducial markers Nasion Tumor's margin (anterior, posterior, superior, inferior)
Intervention Type
Diagnostic Test
Intervention Name(s)
AR-based navigation
Intervention 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. Fiducial markers Nasion Tumor's margin (anterior, posterior, superior, inferior)
Primary Outcome Measure Information:
Title
The degree of 3-dimensional error at each measurement points (mm)
Description
Fiducial markers, nasion
Time Frame
6 hours
Title
The degree of 3-dimensional error at each measurement points (mm) after durotomy
Description
Tumor's margin, ICA bifurcation, et al.
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Non-inferiority of AR-based navigation compared to conventional navigation
Description
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.
Time Frame
12 months
Title
Time required to set up and use each navigation
Description
Time required to match conventional navigation and AR navigation, respectively.
Time Frame
6 hours
Title
Economic analysis for each navigation
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho Kang, MD
Phone
+821085571217
Email
kang.ho85@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chul-Kee Park, MD, PhD
Phone
+82220720347
Email
nsckpark@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chul-Kee Park, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Kang, MD
Phone
+821085571217
Email
kang.ho85@gmail.com
First Name & Middle Initial & Last Name & Degree
Chul-Kee Park, MD, PhD
Phone
+82220720347
Email
nsckpark@snu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Trial for the Validation of AR Based Neuronavigation System

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