Refining Neurosurgical Planning Software For Clinical Use

Research question. Time to plan stereotactic neurosurgery procedures is one factor inhibiting the ability to conduct these procedures in a timely manner, increasing risk for patients with untreated conditions. The EpiNav™ software platform can determine safe, surgically feasible stereotactic trajectories in under 5 minutes. EpiNav™ must now be refined and simplified so clinicians can easily use it. Background. Current commercial systems rely on the neurosurgeons manually plan stereotactic trajectories, requiring between 10 minutes for simple procedures up to 8 hours for the most complex. We have previously demonstrated the efficacy of EpiNav™ to determine the trajectories for stereo-electroencephalography (SEEG) electrode implantations in a single centre prospective study. EpiNav™ reduced planning time by 70%, with 79% of trajectories produced being acceptable to implant without any modification. Aims and Objectives. We will ensure EpiNav™ is fit-for-purpose and derisk commercial investment by: Objective 1: Bringing EpiNav™ into a quality management system (QMS) to meet ISO13485 software standards. Objective 2: Aligning the EpiNav™ user interface (UI) with clinical workflows. Objective 3: Minimising user interactions for pre-processing algorithms in EpiNav™. Methods and Timelines for Delivery. The project has three work packages running for 36 months. Work package 1 (WP1) Optimise Software Workflow: will use agile, iterative development in a tracked time-stamped repository in a QMS to develop the software according to ISO13485 software standards. User feedback to ensure all changes are fit-for-purpose will be gathered through twice monthly interactive sessions with clinicians and a yearly patient focus group. Work package 2 (WP2) Automate Pre-processing Algorithms: brain parcellation and vascular segmentation algorithms will be modified to eliminate the need for user defined parameters, or multiple image processing steps to ensure input images are in the correct format. All algorithm outputs will be benchmarked against a retrospective dataset previously published to guarantee changes do not negatively impact EpiNav™ performance. Work package 3 (WP3) Clinical Testing & Integration: will be performed in a prospective observational study with quarterly releases of EpiNav™ for two stereotactic procedures: brain tumour biopsy (100 patients, 100 needle trajectories) and SEEG electrode implantation (50 patients, approximately 500 electrode trajectories). Patient materials will be reviewed by a patient focus group to ensure inclusive and accessible language. We will assess the suitability of EpiNav™ by performing a group-wise assessment of time to plan for 50 SEEG and 100 BIOPSY trajectories. Secondary assessments on trajectory metrics and qualitative feedback on trajectory suitability by consultant neurosurgeons will also be evaluated. Anticipated Impact and Dissemination. This project will make EpiNav™ fit-for-purpose for use in busy neurosurgical centres by clinical users using a range of robotic guidance systems. This project will produce the necessary technical documentation and clinical data to derisk commercial investment and support an application to the Medicines and Healthcare products Regulatory Agency (MHRA) to make EpiNav™ a regulated medical device. The findings of the project will be presented in scientific and medical journals and conferences. Key findings will be disseminated to the public through traditional, social media, presentations to patient interest groups and public engagement events.