Navigation Support With Mixed Reality With CORTEXPLORER MED (CXmed)

Navigation Support With Mixed Reality for Surgical Clipping of Cerebral Aneurysms in Adult Patients With CORTEXPLORER MED - a Pilot Stage, Exploratory, First in Human Clinical Investigation

During the last 15 years, neuronavigation has become an essential neurosurgical tool for pursuing minimal invasiveness and safety. One drawback of such devices is the fact, that the neurosurgeon has to look away from the surgical field onto a dedicated workstation screen. Additionally, the operator is required to transfer this information from the "virtual" environment of the navigation system to the real surgical field - whereas the real patient may be fixated and positioned differently compared to the visualization on the screen.

Mixed-reality may have the potential to support this, by merging data from the real environment with virtual information and vice-versa. In the context of surgical navigation, the main goal of mixed reality systems is to provide a real-time updated 3D virtual model of anatomical details, overlaid on the real surgical field. In this sense, the mixed reality is the process of enrichment of reality with additional virtual contents.

This clinical investigation aims at the collecting of clinical data about the mixed-reality supported planning, the registration accuracy and overall precision of the navigation system and the clinical outcome.

Study Overview

• Status: Completed
• Conditions: Cranial Aneurysm
• Intervention / Treatment: Device: CORTEXPLORER MED

Detailed Description

The CORTEXPLORER MED system is a platform that enables surgical navigation using radiological images of patients. The application software reads, formats and merges patient-specific multimodal images such as pre-surgical computed tomography (CT), magnetic resonance imaging (MRI, fMRI) as well as intraoperatively taken fluoroscopic scans. These digital representations of the patient are displayed on a computer screen from different anatomical perspectives (axial, sagittal, coronal, diagonal). Moreover, a 3D digital model can be computed based on the 2D imaging data. Before the operation, the surgeon can create, save, and simulate the course along one or more surgical trajectories. During surgery, the system tracks the position of specific surgical instruments in or on the patient's anatomy and continuously updates their position, which can be displayed on a computer screen or trough mixed reality glasses (Microsoft HoloLens).

Generally, this clinical investigation aims at the collecting of clinical data to indicate the difference between the planning of a neurosurgery without and with the mixed reality feature of CORTEXPLORER MED.

Additionally, clinical data is collected to indicate the difference between the planning of a surgery with the CORTEXPLORER MED and without the system (conventional approach for this indication).

The data from this pilot phase are used for the planning of a larger clinical investigation and for the overall clinical evaluation of the navigation system.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Kepler Universitätsklinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients of any gender in the age older or eqal 18 years
• Patients who be informed of the nature of the clinical investigation and provide written informed consent
• Patients with a cerebral aneurysm for which surgical clipping is indicated
• Patients with a cerebral aneurysm where clipping is not routinely supported by navigation
• Patients with current (not longer than 4 months) 3D image data of the brain

Exclusion Criteria:

• Patients for whom required imaging is not available
• Patients with ruptured cerebral aneurysm
• Detained patients
• Patients performing mandatory military service / community service
• Patients who refuse to participate in the clinical investigation
• Pregnant or nursing patients
• Patients who are not able to sign the consent form
• Patients who do not speak German
• Patients who are taking part in any other clinical investigations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CORTEXPLORER MED; Mixed-reality assisted planning of aneurysm clipping with the optical navigation system CORTEXPLORER MED.

Device: CORTEXPLORER MED; The CORTEXPLORER MED system is a platform that enables surgical navigation using real-time radiological images of patients. The application software formats patient-specific computed tomography or magnetic resonance images taken before surgery. These are displayed on the screen and through mixed reality from different perspectives (axial, sagittal, coronal, diagonal). Before surgery, the surgeon can then create, save and simulate the course along one or more surgical trajectories. As a visualization aid, the surgeon can also create and edit one or more 3D models of the anatomy. During surgery, the system tracks the position of specific surgical instruments in or on the patient's anatomy and continuously updates the position of the instruments on these images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated trajectory with mixed-reality (without projection of trajectory)	Difference of angle and position of the estimated trajectory with mixed-reality support and without the projected trajectory compared to the pre-operatively defined trajectory.	Day 0
Estimated trajectory without mixed-reality	Difference of angle and position of the estimated trajectory without mixed reality support (conventional) compared to the pre-operatively defined trajectory.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated trajectory with mixed-reality (with projection of trajectory)	Difference of angle and position of the estimated trajectory with mixed reality support and with the projected trajectory compared to the pre-operatively defined trajectory.	Day 0
Estimated trajectory with navigation support (planning view)	Difference of angle and position of the estimated trajectory with navigation support (planning view) compared to the pre-operatively defined trajectory.	Day 0
Estimated trajectory with navigation support (navigation view)	Difference of angle and position of the estimated trajectory with navigation support (navigation view) and with the projected trajectory compared to the pre-operatively defined trajectory.	Day 0
Planning performance with CORTEXPLORER MED	The distance to vessels and the distance from the cranial surface to the target of the post-surgical planning and the initial estimation of the trajectory (conventional approach).	Day 0, Day 30
Registration accuracy	The registration accuracy is measured with the navigation software in millimeters	Day 0
Usability questionnaire	Usability questionnaire related to the activities preparation, planning, navigation and post-processing [0 - 5]	Day 0, Day 30
Degree of disability or limitation	Degree of disability or limitation in the daily activities of patients after neurological interventions as measured with the Modified Rankin Scale	Day 7
Intraoperative complications	Severity and occurrence of seizures and bleedings and other intraoperative adverse events	Day 0
Postoperative complications	Severity and occurrence of seizures and bleedings and other postoperative adverse events.	Day 1 to Day 7

Collaborators and Investigators

• Sponsor: cortEXplore GmbH
• Collaborators: Raffeiner GmbH
• Investigators: Principal Investigator: Matthias Gmeiner, MD, Johannes-Kepler-University, Department of Neurosurgery

Publications and helpful links

Helpful Links

• Homepage of manufacturer

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Aneurysm; Neurosurgery; Neuronavigation; Surgical navigation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: CXmed_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No