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Completed

NCT Number: NCT05269498

Navigation Support With Mixed Reality With CORTEXPLORER MED

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.

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Key information

Conditions

Cranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kepler Universitätsklinikum

Linz, Upper Austria, 4020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CORTEXPLORER MED

Device

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.

Primary outcomes

  1. Estimated trajectory with mixed-reality (without projection of trajectory)

    Time frame: Day 0

    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.

  2. Estimated trajectory without mixed-reality

    Time frame: Day 0

    Difference of angle and position of the estimated trajectory without mixed reality support (conventional) compared to the pre-operatively defined trajectory.

Secondary outcomes

  1. Estimated trajectory with mixed-reality (with projection of trajectory)

    Time frame: Day 0

    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.

  2. Estimated trajectory with navigation support (planning view)

    Time frame: Day 0

    Difference of angle and position of the estimated trajectory with navigation support (planning view) compared to the pre-operatively defined trajectory.

  3. Estimated trajectory with navigation support (navigation view)

    Time frame: Day 0

    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.

  4. Planning performance with CORTEXPLORER MED

    Time frame: Day 0, Day 30

    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).

  5. Registration accuracy

    Time frame: Day 0

    The registration accuracy is measured with the navigation software in millimeters

  6. Usability questionnaire

    Time frame: Day 0, Day 30

    Usability questionnaire related to the activities preparation, planning, navigation and post-processing [0 - 5]

  7. Degree of disability or limitation

    Time frame: Day 7

    Degree of disability or limitation in the daily activities of patients after neurological interventions as measured with the Modified Rankin Scale

  8. Intraoperative complications

    Time frame: Day 0

    Severity and occurrence of seizures and bleedings and other intraoperative adverse events

  9. Postoperative complications

    Time frame: Day 1 to Day 7

    Severity and occurrence of seizures and bleedings and other postoperative adverse events.

Sponsors and collaborators

Lead sponsor

cortEXplore GmbH

Industry

Collaborators

  • Raffeiner GmbH

Registry information

Official study title

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

Acronym: CXmed

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2022
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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