Investigation of Augmented Reality/Mixed Reality Viewer for Surgical Planning in Cranial Surgery
Brainlab AG
Summary
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
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 Tu…
Interventions
- DeviceMixed Reality Glasses/Viewer
Mixed reality glasses with 3D viewer used to visualize cranitomy planning environment for incision planning and patient positioning
- OtherSurvey using a questionnaire.
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
Location
- Brigham and Women's Hospital, Inc.Boston, Massachusetts