NCT07650253

Brief Summary

Neurosurgery is a high-stakes surgical specialty where errors can result in significant morbidity. The amount of force applied simultaneously on the brain with multiple different instruments during complex neurosurgical procedures is a critical safety metric that, to the investigators' knowledge, has not been previously measured in a realistic operative environment. The investigators have therefore developed a simulation platform integrating an ex vivo calf brain and a 3D-printed skull model attached to a force sensor capable of capturing real-time forces applied to the brain. A case series study will be conducted to evaluate the pattern of force applied. Medical students, neurosurgical residents, and staff neurosurgeons from McGill University will be recruited to perform subpial resections using our ex vivo calf brain simulation platform. The forces applied by the microscissors, bipolar forceps, and ultrasonic aspirator onto the brain will be captured. This study aims to demonstrate the spectrum of force applied during a neurosurgical procedure using an ex vivo calf brain model.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 10, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

Surgical EducationSurgical SimulationForce Measurement

Outcome Measures

Primary Outcomes (1)

  • Forces applied to the brain during each simulated subpial resection procedure step

    Throughout each simulated ex vivo subpial resection procedure, forces applied to the brain during tool-tissue contact will be measured by the force/torque sensor in grams and Newtons.

    1 day of study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Staff neurosurgeons, neurosurgical residents, and medical students from McGill University

You may qualify if:

  • Right-handed medical students, neurosurgical residents, and staff neurosurgeons from McGill University

You may not qualify if:

  • Left-handed individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuro Imaging and Surgical Technologies Lab, Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, McGill University

Montreal, Quebec, H3A 2B4, Canada

RECRUITING

Study Officials

  • Rolando F. Del Maestro, MD, PhD

    Neurosurgical Simulation and Artificial Intelligence Learning Centre, McGill University

    PRINCIPAL INVESTIGATOR
  • Amir Hooshiar, PhD

    Surgical Performance Enhancement and Robotics Centre, McGill University

    STUDY DIRECTOR
  • D. Louis Collins, PhD

    Neuro Imaging and Surgical Technologies Lab, McGill University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neurosurgical Simulation and Artificial Intelligence Learning Centre

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 16, 2026

Study Start

June 1, 2026

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations