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Observational Study of Mixed Reality for Craniotomy Planning

This study is looking at how well a new tool, the Brainlab's Mixed Reality Viewer (special glasses with a 3D view), helps surgeons plan brain tumor removal surgery (craniotomy). It's an observational study, meaning researchers will watch how hospital staff use this tool during standard surgical procedures for adults aged 18 and older who have a brain tumor requiring surgery. The goal is to see if using these mixed reality glasses makes planning the incision (cut) more accurate and efficient compared to traditional methods. The study aims to enroll 54 participants in total. We don't know the current recruitment status.

Study design
This is an observational study with 54 planned participants, divided into two groups. Researchers will watch how the mixed reality device is used during standard surgical procedures.
What's involved
You would undergo standard brain tumor surgery. Hospital personnel will use mixed reality glasses to plan your surgery, and they will complete a survey about their experience.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement of incision planning accuracy happens during the planning stage, from when the neurosurgeon starts planning until the incision is planned in the operating room before draping.

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NCT07468370

Real Time Craniotomy Planning Using Mixed Reality

Not Yet Recruiting
Not specifiedAges 18+Observational
Brainlab AG
~54 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:Mixed Reality Glasses/ViewerSurvey using a questionnaire.

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Quantitative Assessment of Incision Planning Accuracy
Measured over 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

Conditions

Neurosurgery
Surgical Planning
Brain Tumor Adult
Craniotomy Tumor Removal Surgery

Explore related trials

Brain Neoplasm

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Paramjai Sandhu
[email protected]
617-632-3029
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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

What this trial measures

  • Quantitative Assessment of Incision Planning AccuracyDuring 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

    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.