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Real Time Craniotomy Planning Using Mixed Reality

NCT07468370 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2026-03-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Brainlab AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07468370 on ClinicalTrials.gov