Oxford Heartbeat has announced the completion of patient recruitment for its clinical trial evaluating the impact of PreSize Neurovascular software, an artificial intelligence (AI)-powered tool designed to support decision-making in neurovascular surgery. This milestone marks a significant step in assessing the role of AI in optimizing treatment strategies for cerebral aneurysms.
The trial, funded by the UK’s National Institute for Health and Care Research (NIHR) AI in Health and Care Award, is a registered and ethics-approved prospective, multicentre study. It is being independently run by the Imperial Clinical Trials Unit (London, UK) and involves the participation of nine centers across the UK and a total of 25 surgeons.
The study focuses on patients diagnosed with cerebral aneurysms who are scheduled for minimally invasive treatment via the placement of a flow-diverting stent. These stents redirect blood flow away from the aneurysm, reducing the risk of rupture. Selecting the optimal stent size for each patient is a complex challenge, and suboptimal choices can lead to device wastage, surgical inefficiencies, and patient complications.
How PreSize Neurovascular Software Works
PreSize Neurovascular software allows for real-time, virtual rehearsal of treatment scenarios, enabling clinical teams to determine the most appropriate device before the actual procedure. The software is CE-mark certified, indicating compliance with safety and performance requirements for medical software. Previous studies have demonstrated the software's accuracy in informing clinical decisions and its positive impact on clinical decision-making.
The trial compares clinical decision-making using traditional methods versus those supported by PreSize. Data is being collected on surgical efficiency metrics, such as the number of devices used and the duration of surgery. Oxford Heartbeat emphasizes that this trial is unique in its prospective collection of data to demonstrate the objective and measurable benefits of software use for patients and clinical teams in a real-world setting.
Next Steps
With patient recruitment now complete, the Imperial Clinical Trials Unit statistics team will analyze the collected dataset. The full results of the trial will be published in due course.
