Navigation Support With Mixed Reality With CORTEXPLORER MED

NCT05269498 | Completed DMC

• 1 other identifier: CXmed_001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cranial Aneurysm

Keywords

Neuronavigation; Neurosurgery; Aneurysm; Surgical navigation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Estimated trajectory with mixed-reality (with projection of trajectory)

  Day 0

• Estimated trajectory with navigation support (planning view)

  Day 0

• Estimated trajectory with navigation support (navigation view)

  Day 0

• Planning performance with CORTEXPLORER MED

  Day 0, Day 30

• Registration accuracy

  Day 0

Study Arms (1)

CORTEXPLORER MED

EXPERIMENTAL

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

Device: CORTEXPLORER MED

Interventions

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.

CORTEXPLORER MED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• cortEXplore GmbH: lead
• Raffeiner GmbH: collaborator

Study Sites (1)

Kepler Universitätsklinikum

Linz, Upper Austria, 4020, Austria

Location

Related Links

• Homepage of manufacturer

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Matthias Gmeiner, MD

  Johannes-Kepler-University, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 8, 2022
• Study Start: June 8, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)