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NCT07583082

Validation of an Ex Vivo Calf Brain Force Detection System for Neurosurgical Simulation Training

Sponsor: McGill University

View on ClinicalTrials.gov

Summary

Neurosurgery is a high-stakes surgical specialty where errors can result in significant patient mortality and morbidity. The amount of force applied on the brain simultaneously by the 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 cross-sectional case series study will be conducted to evaluate the validity of the system. Medical students, neurosurgical residents, neurosurgical fellows, and staff neurosurgeons from four Quebec institutions will be recruited to perform three simulated subpial resections each 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 along with kinematic data. This study aims to establish the face, content, construct, and convergent validity of this ex vivo calf brain force detection system.

Official title: Validation of an Ex Vivo Calf Brain Force Detection System for Neurosurgical Simulation Training: A Case Series Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-05

Completion Date

2026-09

Last Updated

2026-05-13

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Observational

As such, no interventions are provided. All participants will perform three subpial resections on an ex vivo calf brain.

Locations (1)

Neuro Imaging and Surgical Technologies Lab, Montreal Neurological Institute and Hospital, McGill University

Montreal, Quebec, Canada