Neoplasms

Digestive System Diseases

All Conditions

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

microwave ablation is performed laparoscopically with navigation

microwave ablation is performed laparoscopically with ultrasound guidance

the laparoscopic microwave ablation in the pig liver is performed with the CasOne-Spot system

navigated microwave ablation

the laparoscopic microwave ablation iin the pic liver is performed with ultrasound guidance

ultrasound guided navigation

Roger Wahba, MD, PhD

In primary and secondary liver tumors microwave ablation could be an alternative to surgical resection.It could be performed laparoscopically. Under ultrasound control the microwave device is placed in the tumor.Therefore spatial orientation is challenging: the tumor is often missed and the failure rate is high. During learning curve this could lead to incomplete tumor ablation and high rate of local recurrence. Targeting systems could optimize that. The CasOne-SPOT-system is an innovative electromagnetic tracking and navigation system for laparoscopic microwave ablation. In this study targeting precision using the SPOT-System should be compared to conventional laparoscopic ultrasound-guided microwave ablation. Therefore tumor mimics (1-2cm) will be created in ex-vivo pig livers and microwave ablation will be performed ultrasound guided or ultrasound navigated. The ablation procedures will be performed by two novices and two experienced surgeons. Aim of this trial is to is to evaluate, if laparoscopic microwave ablation could be facilitated by the use of the SPOT-navigation system.

Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Trial

Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Single Center Trial

time from beginning of the targeting process until to complete ablation of the tumor mimic

the tumor in relation to the ablation figure is measures and the and and the completeness of the microwave ablation is evaluated

Universitätsklinikum Köln

Principal Investigator

Heart and Blood Diseases

Diseases and Abnormalities at or Before Birth

Nervous System Diseases

Rare Diseases

Aneurysm

Arteriovenous Malformations

Congenital Abnormalities

Brain Neoplasms

Intracranial Arteriovenous Malformations

Intracranial Aneurysm

Vascular Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Vascular Malformations

Cardiovascular Abnormalities

Intracranial Arterial Diseases

Cerebrovascular Disorders

Central Nervous System Vascular Malformations

Nervous System Malformations

Intracranial Arteriovenous Malformation

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)

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)

AR-based navigation

Ho Kang, MD

Chul-Kee Park, MD, PhD

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.

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.

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

Clinical Trial for the Validation of AR Based Neuronavigation System

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

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 match conventional navigation and AR navigation, respectively.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Trial	NCT04106453	Liver Cancer Surgery Navigation, Spa...	navigated micro... ultrasound guid...	-	Universitätsklinikum Köln
Clinical Trial for the Validation of AR Based Neuronavigation System	NCT05776706	Brain Neoplasms Cerebral Aneury... Cerebral Arteri... Navigation, Spa...	AR-based naviga...	18 Years - 85 Years	Seoul National University Hospital
Clinical Trial for the Validation of AR Based Neuronavigation System	NCT05776706	Brain Neoplasms Cerebral Aneury... Cerebral Arteri... Navigation, Spa...	AR-based naviga...	18 Years - 85 Years	Seoul National University Hospital

Spots Global Cancer Trial Database for navigation, spatial