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Can mixed reality make brain surgery safer?

NCT ID NCT07468370

Knowledge-focused Sponsor: Brainlab AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether mixed reality glasses can help surgeons plan incisions for brain tumor removal more accurately and quickly than current methods. About 54 adults needing brain surgery will be observed as surgeons use the device during standard care. The goal is to see if the technology improves planning precision and saves time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mixed reality glasses/viewer
What this could lead to
If successful, this could show that mixed reality helps surgeons plan incisions more accurately and quickly, potentially improving outcomes for brain tumor surgery.
What could go wrong
This is a small, early observational study, not a large trial. It may not prove the device works better than current methods, and results may not apply to all hospitals or surgeries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

brain cancer brain neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain tumor adult Craniotomy tumor removal surgery Neurosurgery Surgical planning

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham and Women's Hospital, Inc.

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.