Clinical Trial

Real Time Craniotomy Planning Using Mixed Reality

Not Yet Recruiting
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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
Trial Details
NCT Number NCT07468370
Lead Sponsor Brainlab AG
Conditions Neurosurgery, Surgical Planning, Brain Tumor Adult, Craniotomy Tumor Removal Surgery
Enrollment 54 participants
Start Date 2026-06
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-03-12