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Navigation Support With Mixed Reality With CORTEXPLORER MED

NCT05269498 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-09-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Raffeiner GmbH

    collaborator INDUSTRY

  • cortEXplore GmbH

    lead INDUSTRY

Principal Investigators

  • Matthias Gmeiner, MD · Johannes-Kepler-University, Department of Neurosurgery

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05269498 on ClinicalTrials.gov