Real Time Craniotomy Planning Using Mixed Reality

N/ANot Yet RecruitingNCT07468370

Brainlab AG54 enrolled

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neurosurgery Surgical Planning Brain Tumor Adult Craniotomy Tumor Removal Surgery

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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 Outcomes

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.

Time frame: From when the craniotomy incision planning begins in the OR and ends before draping the subject

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.

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)

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.

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

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.

Time frame: 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.

Time frame: 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.