Halfway Point Reached in Clinical Impact Trial of PreSize® Neurovascular
London, 20th December 2023 – Oxford Heartbeat is proud to announce that our ongoing clinical impact trial of PreSize® Neurovascular, which is the first of its kind for decision-support software in the field and featured on BBC Click earlier this year, has reached the halfway point in recruitment. The trial, funded by the UK’s National Institute for Health and Care Research’s (NIHR) prestigious AI in Health and Care Award, is set to recruit 100 participants from 10 centres across the UK. Reaching the halfway point means that within the trial, 50 patients have been recruited for whom PreSize was used to inform the surgical planning. This is a significant milestone for PreSize Neurovascular, but also more generally for setting a standard of clinical evidence generation regarding the use of artificial intelligence software to support clinical decision making, within and beyond the field of neurovascular surgery.
The registered and ethics-approved prospective, multi-centre trial is independently run by Imperial Clinical Trials Unit and aims to quantify the benefits of using PreSize in clinical practice. PreSize is CE-mark certified (compliant with safety/performance requirements for medical software) and has undergone rigorous testing; 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. This clinical trial is the only one in the field where data is prospectively collected to demonstrate and quantify the benefits that the use of software can have for patients and clinical teams in a real-world setting.
Thirteen surgeons from across the UK have so far taken part in the study, recruiting the first 50 patients. These are patients who were diagnosed with a cerebral aneurysm and scheduled to be treated minimally invasively, by placing a small stent (flow diverter) into the affected blood vessel, to divert blood away from the aneurysm and minimise the risk of the aneurysm rupturing. Choosing the best-fit device, from the hundreds of options available, for each unique patient case is challenging. Suboptimal choices resulting from current planning methods can lead to device wastage and surgical inefficiencies, which could in turn result in serious patient complications. AI-powered PreSize software allows real-time virtual rehearsal of treatment scenarios, so the clinical team can determine the optimal device before starting the procedure.
The trial compares the clinical decision making between traditional methods (without PreSize) and 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). Now that the study has reached its halfway point, the Imperial Clinical Trials Unit statistics team will analyse the dataset. Interim results will be presented and published on some of the main trial objectives, to provide a first insight into the progress of the study so far. Full dataset analysis and results will be presented when the trial concludes.
Oxford Heartbeat would like to thank the clinicians and clinical research teams involved in the trial for their commitment and interest in this landmark undertaking. We would also like to thank the participants for agreeing to take part in the study, which will further our understanding of the impact of new technologies in patient care. With the collaborative work of researchers, clinicians, engineers and trial experts, we believe that this trial brings us one step closer to a future where safe and successful surgeries are the norm for every patient.
Note to editors
