Real Time Craniotomy Planning Using Mixed Reality

Brainlab

Status: Begins enrollment this month

Conditions: Surgical Planning; Neurosurgery; Craniotomy Tumor Removal Surgery; Brain Tumor Adult

Treatments: Other: Survey using a questionnaire.; Device: Mixed Reality Glasses/Viewer

Study type: Observational

Funder types: Industry

Identifiers

NCT07468370

24-653

Details and patient eligibility

About

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

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

54 participants in 2 patient groups

Brain Tumor Group

Description:

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

Treatment:

Device: Mixed Reality Glasses/Viewer

Survey Group

Description:

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

Treatment:

Other: Survey using a questionnaire.