Status:
COMPLETED
Navigation Support With Mixed Reality With CORTEXPLORER MED
Lead Sponsor:
cortEXplore GmbH
Collaborating Sponsors:
Raffeiner GmbH
Conditions:
Cranial Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05269498
Start Date
June 8 2022
End Date
June 1 2023
Last Update
September 7 2023
Active Locations (1)
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1
Kepler Universitätsklinikum
Linz, Upper Austria, Austria, 4020