Real Time Craniotomy Planning Using Mixed Reality
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mixed Reality Glasses/Viewer, Survey using a questionnaire..
- Who it may be relevant to
- Registry conditions: Neurosurgery, Surgical Planning, Brain Tumor Adult, Craniotomy Tumor Removal Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigation of Augmented Reality/Mixed Reality Viewer for Surgical Planning in Cranial Surgery
Overview
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
Interventions
- Device Mixed Reality Glasses/Viewer
Mixed reality glasses with 3D viewer used to visualize cranitomy planning environment for incision planning and patient positioning - Other Survey 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
Primary outcome measures
- Quantitative Assessment of Incision Planning Accuracy [Time frame: 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]
Secondary outcome measures (6)
- Quantitative Analysis of Incision Time [Time frame: From when the craniotomy incision planning begins in the OR and ends before draping the subject]
- Quantitative Analysis of Craniotomy Planning Time [Time frame: 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) [Time frame: 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 [Time frame: From the time craniotomy planning begins in the OR and ends before draping the subject]
- Qualitative Assessment of User Satisfaction [Time frame: through study completion, an average of 1 year]
- Evaluation of Device Safety [Time frame: through study completion, an average of 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Brigham and Women's Hospital, Inc. — Boston
Identifiers
NCT: NCT07468370 · 24-653