Real Time Craniotomy Planning Using Mixed Reality

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brainlab AG
Study ID
NCT07468370
Status
Not Yet Recruiting

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Conditions

  • Brain Tumor Adult
  • Craniotomy Tumor Removal Surgery
  • Neurosurgery
  • Surgical Planning

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
54 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's Hospital, Inc.BostonMassachusetts02115
Paramjai Sandhu
[email protected]
617-632-3029

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By research site
Brigham and Women's Hospital, Inc.· Boston, MA

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