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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain Tumor Group | Subjects with a brain tumor requiring surgical intervention and scheduled to undergo craniotomy where planning of incision and patient positioning is needed |
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| Survey Group | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mixed Reality Glasses/Viewer | Device | Mixed reality glasses with 3D viewer used to visualize cranitomy planning environment for incision planning and patient positioning |
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| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Assessment of Incision Planning Accuracy | Determine whether the Mixed Reality Viewer improves the accuracy of incision planning compared to standard neuronavigation. This will be measured by comparing the deviation between the planned and actual incision locations in both methods. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Analysis of Incision Time | Assess whether the use of the Mixed Reality Viewer leads to a reduction in the time taken to perform the incision, compared to the standard neuronavigation incision planning. | From when the craniotomy incision planning begins in the OR and ends before draping the subject |
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Brain Tumor Group Inclusion Criteria:
Brain Tumor Group Exclusion Criteria:
Survey Group Inclusion Criteria:
Survey Group Exclusion Criteria:
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Adult patients diagnosed with a brain tumor scheduled to undergo surgical intervention where craniotomy planning is needed to plan incision and patient positioning.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital, Inc. | Boston | Massachusetts | 02115 | United States |
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| Survey using a questionnaire. | Other | A survey will be completed by hospital personnel that use the mixed reality environment (glasse and viewer) to evaluate craniotomy planning for participants in the Brain Tumor Group |
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| Quantitative Analysis of Craniotomy Planning Time |
Evaluate if the Mixed Reality Viewer decreases the time required to plan the craniotomy compared to standard neuronavigation planning methods. |
| From the time craniotomy planning begins in the OR and ends before draping the subject |
| Qualitative Assessment of Planning Ease Using NASA Task Load Index (TLX) | Assess whether the Mixed Reality Viewer improves the ease and overall user experience of operative planning as compared to standard methods, using the NASA TLX survey tool for subjective workload assessment. | From the start of using the Mixed Reality environment for craniotomy planning in the OR to the final plan before draping the subject |
| Quantitative Analysis of Overall Surgical Time | Measure the overall time from the beginning of the surgical planning to the completion of the incision to determine if the Mixed Reality Viewer contributes to a more efficient surgical workflow. | From the time craniotomy planning begins in the OR and ends before draping the subject |
| Qualitative Assessment of User Satisfaction | Collect feedback from surgeons and surgical staff regarding their satisfaction with the Mixed Reality Viewer compared to standard methods, using structured interviews or surveys. | through study completion, an average of 1 year |
| Evaluation of Device Safety | Monitor and record any adverse events or complications associated with the use of the Mixed Reality Viewer during the surgical planning and execution phases. | through study completion, an average of 1 year |