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NCT07468370

Real Time Craniotomy Planning Using Mixed Reality

Sponsor: Brainlab AG

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-06

Completion Date

2027-06

Last Updated

2026-03-12

Healthy Volunteers

Not specified

Conditions

Neurosurgery Surgical Planning Brain Tumor Adult Craniotomy Tumor Removal Surgery

Interventions

DEVICE

Mixed Reality Glasses/Viewer

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

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

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

Locations (1)

Brigham and Women's Hospital, Inc.

Boston, Massachusetts, United States