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NCT Number: NCT07468370

Real Time Craniotomy Planning Using Mixed Reality

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

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Key information

Conditions

Neurosurgery Brain Tumor Adult Craniotomy Tumor Removal Surgery Surgical Planning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital, Inc.

Boston, Massachusetts, 02115, United States

Location contact

Paramjai Sandhu

CONTACT

[email protected]

617-632-3029

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mixed Reality Glasses/Viewer

Device

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

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Brainlab AG

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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