Real Time Craniotomy Planning Using Mixed Reality
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBrainlab AG
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
Adult patients diagnosed with a brain tumor scheduled to undergo surgical intervention where craniotomy planning is needed to plan incision and patient positioning.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Mixed Reality Glasses/Viewer
DeviceMixed reality glasses with 3D viewer used to visualize cranitomy planning environment for incision planning and patient positioning
Survey using a questionnaire.
Other interventionA 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
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Brain Tumor Group1 intervention
Group B: Survey Group1 intervention
Trial outcomes
Primary outcomes
1
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 drapingSecondary outcomes
1
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 subject2
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 subject3
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 subject4
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 subjectSponsors and contacts
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Source ClinicalTrials.gov
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