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Набор скоро начнётся NCT05776706

Clinical Trial for the Validation of AR Based Neuronavigation System

Без фазы С лечением Brain Neoplasms Cerebral Aneurysm Cerebral Arteriovenous Malformation Navigation, Spatial

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: AR-based navigation.
Кому может быть актуально
Состояния в реестре: Brain Neoplasms, Cerebral Aneurysm, Cerebral Arteriovenous Malformation, Navigation, Spatial. Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Clinical Trial for the Evaluation of the Accuracy of Augmented Reality Based Neuronavigation System

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест AR-based navigation
    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)

Первичные конечные точки

  • The degree of 3-dimensional error at each measurement points (mm) [Срок оценки: 6 hours]
  • The degree of 3-dimensional error at each measurement points (mm) after durotomy [Срок оценки: 6 hours]
Вторичные конечные точки (3)
  • Non-inferiority of AR-based navigation compared to conventional navigation [Срок оценки: 12 months]
  • Time required to set up and use each navigation [Срок оценки: 6 hours]
  • Economic analysis for each navigation [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

South Korea · 1 центр
  • Seoul National University Hospital — Seoul

Идентификаторы

NCT: NCT05776706 · SNUH-AR001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗