Oxford Heartbeat completes patient recruitment in trial evaluating PreSize Neurovascular software

A company press release describes this as a “huge milestone” as the trial—which is funded by the UK’s National Institute for Health and Care Research’s (NIHR) prestigious AI in Health and Care Award—is the first of its kind for decision-support software in the field. The trial therefore “sets a standard of evidence generation” regarding the use of AI software to support clinical decision-making in neurovascular surgery and beyond, the release adds.

The registered and ethics-approved prospective, multicentre trial is being independently run by Imperial Clinical Trials Unit (London, UK), with the aim of quantifying the benefits of using PreSize in clinical practice. In order to achieve this, 100 patients for whom PreSize was used to inform their treatment were recruited onto the trial. Overall, there was participation from nine centres across the UK and a total of 25 surgeons.

Patients included in the trial were diagnosed with a cerebral aneurysm and scheduled to be treated minimally invasively via placement of a flow-diverting stent into the affected blood vessel, to divert blood away from the aneurysm and minimise the risk of it rupturing.

Oxford Heartbeat’s recent release notes that choosing the best-fit device for each patient is challenging, and suboptimal choices resulting from current planning methods can lead to device wastage, surgical inefficiencies and patient complications.

However, PreSize allows real-time, virtual rehearsal of treatment scenarios so that the clinical team can determine the optimal device before starting the procedure. The software is CE-mark certified—meaning it is compliant with safety/performance requirements for medical software—and has undergone rigorous testing, as published studies have shown that it can be reliably used to inform clinical decisions with high levels of accuracy and can positively impact clinical decision-making.

The now-complete trial is comparing the clinical decision-making between traditional methods, without PreSize, versus with PreSize. When PreSize is used to support the selection of implants, information is collected on surgical efficiency metrics—such as devices used in the procedure and duration of surgery. It is the only such trial in the field where data are prospectively collected to demonstrate objective and measurable benefits that the use of software can bring to patients and clinical teams in a real-world setting, Oxford Heartbeat claims.

Now that the study recruitment has been completed, the Imperial Clinical Trials Unit statistics team will analyse the dataset and the full results will be published in due course, the company’s recent release also states.