NCT07468370

Real Time Craniotomy Planning Using Mixed Reality

Investigation of Augmented Reality/Mixed Reality Viewer for Surgical Planning in Cranial Surgery

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 54 (estimated)
• Sponsor: Brainlab AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Conditions

• Neurosurgery
• Surgical Planning
• Brain Tumor Adult
• Craniotomy Tumor Removal Surgery

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study