Real Time Craniotomy Planning Using Mixed Reality

March 11, 2026 updated by: Brainlab AG

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital, Inc.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

Brain Tumor Group Inclusion Criteria:

  • 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.

Brain Tumor Group Exclusion Criteria:

  • 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).

Survey Group Inclusion Criteria:

  • 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.

Survey Group Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Mixed reality glasses with 3D viewer used to visualize cranitomy planning environment for incision planning and patient positioning
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quantitative Assessment of Incision Planning Accuracy
Time Frame: 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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quantitative Analysis of Incision Time
Time Frame: From when the craniotomy incision planning begins in the OR and ends before draping the subject
Assess whether the use of the Mixed Reality Viewer leads to a reduction in the time taken to perform the incision, compared to the standard neuronavigation incision planning.
From when the craniotomy incision planning begins in the OR and ends before draping the subject
Quantitative Analysis of Craniotomy Planning Time
Time Frame: From the time craniotomy planning begins in the OR and ends before draping the subject
Evaluate if the Mixed Reality Viewer decreases the time required to plan the craniotomy compared to standard neuronavigation planning methods.
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)
Time Frame: From the start of using the Mixed Reality environment for craniotomy planning in the OR to the final plan before draping the subject
Assess whether the Mixed Reality Viewer improves the ease and overall user experience of operative planning as compared to standard methods, using the NASA TLX survey tool for subjective workload assessment.
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
Time Frame: From the time craniotomy planning begins in the OR and ends before draping the subject
Measure the overall time from the beginning of the surgical planning to the completion of the incision to determine if the Mixed Reality Viewer contributes to a more efficient surgical workflow.
From the time craniotomy planning begins in the OR and ends before draping the subject
Qualitative Assessment of User Satisfaction
Time Frame: through study completion, an average of 1 year
Collect feedback from surgeons and surgical staff regarding their satisfaction with the Mixed Reality Viewer compared to standard methods, using structured interviews or surveys.
through study completion, an average of 1 year
Evaluation of Device Safety
Time Frame: through study completion, an average of 1 year
Monitor and record any adverse events or complications associated with the use of the Mixed Reality Viewer during the surgical planning and execution phases.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brainlab AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-653

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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