Navigation Support With Mixed Reality With CORTEXPLORER MED (NCT05269498) | Clinical Trial Compass
CompletedNot Applicable
Navigation Support With Mixed Reality With CORTEXPLORER MED
Austria15 participantsStarted 2022-06-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Estimated trajectory with mixed-reality (without projection of trajectory)