Real Time Craniotomy Planning Using Mixed Reality

NCT07468370 | Not Yet Recruiting FDA Device

• 1 other identifier: 24-653
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mixed reality; craniotomy planning; tumor localization

Outcome Measures

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.

  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 (6)

• Quantitative Analysis of Incision Time

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

• Quantitative Analysis of Craniotomy Planning Time

  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)

  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

  From the time craniotomy planning begins in the OR and ends before draping the subject

• Qualitative Assessment of User Satisfaction

  through study completion, an average of 1 year

Study Arms (2)

Brain Tumor Group

Subjects with a brain tumor requiring surgical intervention and scheduled to undergo craniotomy where planning of incision and patient positioning is needed

Device: Mixed Reality Glasses/Viewer

Survey Group

Hospital personnel that will be operating or assisting in the craniotomy planning and positioning of subjects enrolled in the Brain Tumor Group and will complete a survey on their experience using the Mixed Reality Viewer

Other: Survey using a questionnaire.

Interventions

Mixed Reality Glasses/Viewer DEVICE

Mixed reality glasses with 3D viewer used to visualize cranitomy planning environment for incision planning and patient positioning

Brain Tumor Group

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

Survey Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with a brain tumor scheduled to undergo surgical intervention where craniotomy planning is needed to plan incision and patient positioning.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• Inability to Provide Informed Consent: Hospital personnel is unable to provide written informed consent

Sponsors & Collaborators

• Brainlab AG: lead

Study Sites (1)

Brigham and Women's Hospital, Inc.

Boston, Massachusetts, 02115, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)