Cranial AneurysmCXmedNCT05269498
Navigation Support With Mixed Reality With CORTEXPLORER MED
A study testing CORTEXPLORER MED in people with Cranial Aneurysm, run by cortEXplore GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cranial Aneurysm
- What is being tested?
- CORTEXPLORER MED
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- 8 Jun 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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 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.
- Conditions
- Cranial Aneurysm
- Being tested
- CORTEXPLORER MED
- Keywords
- Neuronavigation, Neurosurgery, Aneurysm, Surgical navigation
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORTEXPLORER MEDDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CORTEXPLORER MED | Experimental | Mixed-reality assisted planning of aneurysm clipping with the optical navigation system CORTEXPLORER MED. Receives: Device: CORTEXPLORER MED |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0
Secondary outcomes (9)
Estimated trajectory with mixed-reality (with projection of trajectory)
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.
Measured: Day 0
Estimated trajectory with navigation support (planning view)
Difference of angle and position of the estimated trajectory with navigation support (planning view) compared to the pre-operatively defined trajectory.
Measured: Day 0
Estimated trajectory with navigation support (navigation view)
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.
Measured: Day 0
Planning performance with CORTEXPLORER MED
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).
Measured: Day 0, Day 30
Registration accuracy
The registration accuracy is measured with the navigation software in millimeters
Measured: Day 0
Usability questionnaire
Usability questionnaire related to the activities preparation, planning, navigation and post-processing [0 - 5]
Measured: Day 0, Day 30
Degree of disability or limitation
Degree of disability or limitation in the daily activities of patients after neurological interventions as measured with the Modified Rankin Scale
Measured: Day 7
Intraoperative complications
Severity and occurrence of seizures and bleedings and other intraoperative adverse events
Measured: Day 0
Postoperative complications
Severity and occurrence of seizures and bleedings and other postoperative adverse events.
Measured: Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start8 Jun 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- cortEXplore GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Raffeiner GmbH
- Responsible party
- Sponsor
- Investigators
- Matthias Gmeiner, MD, Principal investigator, Johannes-Kepler-University, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269498
- Sponsor's protocol ID
- CXmed_001
- Acronym
- CXmed
- Status last verified
- Sep 2023
- First submitted
- 25 Feb 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05269498
- Acronym / sponsor ID
- CXmed / CXmed_001
- Conditions
- Cranial Aneurysm
- Keywords
- Neuronavigation, Neurosurgery, Aneurysm, Surgical navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- cortEXplore GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Raffeiner GmbH
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CORTEXPLORER MED | Experimental | Device: CORTEXPLORER MEDMixed-reality assisted planning of aneurysm clipping with the optical navigation system CORTEXPLORER MED. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CORTEXPLORER MEDThe 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. | Device | CORTEXPLORER MED |
Primary outcome
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.
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.
9 secondary outcomes
Estimated trajectory with mixed-reality (with projection of trajectory)
Time frame: Day 0
Estimated trajectory with navigation support (planning view)
Time frame: Day 0
Estimated trajectory with navigation support (navigation view)
Time frame: Day 0
Planning performance with CORTEXPLORER MED
Time frame: Day 0, Day 30
Registration accuracy
Time frame: Day 0
Usability questionnaire
Time frame: Day 0, Day 30
Degree of disability or limitation
Time frame: Day 7
Intraoperative complications
Time frame: Day 0
Postoperative complications
Time frame: Day 1 to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Homepage of manufacturerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Gmeiner, MD principal investigator
Johannes-Kepler-University, Department of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CORTEXPLORER MED in people with Cranial Aneurysm, run by cortEXplore GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated trajectory with mixed-reality (without projection of trajectory) (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.