Clinical trial · Observational
Real Time Craniotomy Planning Using Mixed Reality
Investigation of Augmented Reality/Mixed Reality Viewer for Surgical Planning in Cranial Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective observational study designed to evaluate the effectiveness of Brainlab's Mixed Reality Viewer in enhancing the accuracy and efficiency of preoperative craniotomy planning. The study will be conducted at a single site with two enrollment groups. Group 1 has a target enrollment of 38 subjects. Group 2 has a target enrollment of 16 subjects. By observing the device's use during standard surgical procedures, we can accurately measure its impact on incision planning accuracy, time efficiency, and overall ease of use compared to traditional neuronavigation systems. This design allows for the collection of both quantitative and qualitative data, providing a robust assessment of the Mixed Reality Viewer's potential to enhance surgical outcome
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor Adult | Brain Neoplasm | ALIAS | 0.85 |
| Craniotomy Tumor Removal Surgery | — | UNRESOLVED | — |
| Neurosurgery | — | UNRESOLVED | — |
| Surgical Planning | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mixed Reality Glasses/Viewer | Device | — | UNRESOLVED |
| Survey using a questionnaire. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Brain Tumor Group
- description
- Subjects with a brain tumor requiring surgical intervention and scheduled to undergo craniotomy where planning of incision and patient positioning is needed
- interventionNames
- Device: Mixed Reality Glasses/Viewer
- label
- Survey Group
- description
- Hospital personnel that will be operating or assisting in the craniotomy planning and positioning of subjects enrolled in the Brain Tumor Group and will complete a survey on their experience using the Mixed Reality Viewer
- interventionNames
- Other: Survey using a questionnaire.
Primary outcomes (1)
- measure
- Quantitative Assessment of Incision Planning Accuracy
- timeFrame
- During the craniotomy incision planning stage that starts when Neurosurgeon begins planning incision on pre-operative cranial planning software (typically the day before surgery) and ends when the incision has been planned in the OR before draping
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Brain Tumor Group Inclusion Criteria: * Diagnosis: Patients diagnosed with a brain tumor requiring surgical intervention. * Age: Adults aged 18 years and older. * Consent: Patients who are able to provide written informed consent and are willing to comply with study procedures. * Preoperative Imaging: Patients who have undergone standard of care preoperative imaging (e.g., MRI, CT) suitable for use with the Brainlab Mixed Reality Viewer. * Surgical Eligibility: Patients deemed eligible for craniotomy based on current clinical standards and the judgment of the attending neurosurgeon. Brain Tumor Group Exclusion Criteria: * Inability to Provide Informed Consent: Subject is unable to provide written informed consent due to cognitive impairment, language barriers, or other reasons that preclude them from understanding the study's requirements. * Emergency Surgery: Subject requires emergency craniotomy where there is insufficient time to perform preoperative planning with the Mixed Reality Viewer. * Concurrent Participation in Other Clinical Trials: Subject is currently enrolled in another clinical trial that could interfere with the results of this study or place additional burdens on the subject. * Unstable Clinical Condition: Subject has a medical condition that is unstable or severe enough to preclude safe participation in the study, as determined by the investigator (e.g., severe cardiac or respiratory conditions). Survey Group Inclusion Criteria: * Hospital Personnel: Includes hospital personnel operating or assisting in the brain tumor resection surgeries where the study device is being utilized on an enrolled subject in the study. This includes the Investigators, Clinical Research Coordinator, OR Nurses, and Residents. * Age: Adults aged 18 years and older. * Consent: Hospital personnel who are able to provide written informed consent and are willing to complete the survey. Survey Group Exclusion Criteria: * Inability to Provide Informed Consent: Hospital personnel is unable to provide written informed consent
References
Publications (0)
Data not yet available