Computer Vision for Real-Time Anatomical Navigation in Neurosurgery: First-in-Human Clinical Evaluation and Iterative Development (IDEAL Stage 1)
Introduction: Precise anatomical navigation is fundamental to safe endoscopic pituitary surgery, a high-stakes procedure characterised by a challenging learning curve. While traditional navigation systems often rely on workflow-disrupting probes or static preoperative imaging, advancements in computer vision AI (CVAI) now enable dynamic, real-time anatomical segmentation directly from live surgical video1-3. Our group has previously conducted a series of preclinical human-computer interaction studies to refine the system's design, alongside digital and high-fidelity physical simulations demonstrating the benefit of AI assistance in improving overall performance, training, and safety4-8. Building on this foundation, the current study represents a first-in-human application of real-time CVAI assistance in the neurosurgical operating room, serving to assess feasibility and safety, and to iteratively improve the system. Method: Guided by DECIDE-AI and IDEAL frameworks, this single-centre evaluation comprises an initial proof-of-concept phase (n=6) for endoscopic transsphenoidal pituitary surgeries. The AI model utilised a DINOv3-derived vision transformer architecture, deployed via a high-performance edge computing unit to achieve low-latency, real-time inference without reliance on cloud infrastructure2. Given the high-risk nature of the procedure and the early stage of clinical AI integration, the system was initially deployed as an educational adjunct on a secondary monitor, ensuring the primary surgical feed remains uncompromised. Functionality and safety were assessed via structured questionnaire, prospective observation, and blinded retrospective review of the recordings of the endoscopic surgical video feed and wider operating room environment. Continuous multi-stakeholder feedback through validated human factors surveys drove iterative technical refinements between cases. Results: Six patients with pituitary adenomas were enrolled. The CVAI system was successfully deployed in four cases, demonstrating acceptable real-time sella segmentation accuracy. Deployment failed pre-operatively in two cases owing to a single recurring system reboot bug. Iterative refinement between cases were driven by our experience and surgical team feedback. This resulted in the integration of additional anatomical structure segmentations (e.g., carotid arteries), enhanced model accuracy via training dataset expansion, and hardware firmware upgrades. Multi-stakeholder surveys demonstrated satisfactory system feasibility, usability, and acceptability among the surgical team. Both prospective observation and retrospective video review confirmed the absence of adverse events, including no significant distraction to the primary surgeon, and there were no AI-related clinical complications. Conclusion: This first-in-human early clinical evaluation demonstrates the feasibility, safety and iterative development of real-time, CVAI-based anatomical navigation during high-stakes neurosurgery. Future work will include a larger single-centre case series (IDEAL Stage 2a) with more surgical teams to further iterate the system and explore its impact on training and workflow. As the underpinning technology improves, deployment will transition to direct intra-operative decision support and integration with other intra-operative navigational technologies.