Oxford Heartbeat has announced that its ongoing clinical impact trial of PreSize Neurovascular—a CE mark-certified, “first of its kind” for decision-support software in the field that also featured on BBC Click earlier this year—has reached the halfway point in recruitment.
The trial, funded by the UK 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 surgical planning.
An Oxford Heartbeat press release notes that this is a “significant milestone” for PreSize, but also more generally for setting a standard of clinical evidence generation regarding the use of artificial intelligence (AI) software to support clinical decision-making within and beyond the field of neurovascular surgery.
Oxford Heartbeat’s prospective, multicentre trial—for which the company announced ethics and compliance approval back in November 2021—is being independently run by Imperial Clinical Trials Unit (ICTU; London, UK) and aims to quantify the benefits of using PreSize in clinical practice. This clinical trial is “the only one in the field” where data are 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, Oxford Heartbeat’s recent release states.
The company further notes that PreSize has undergone rigorous testing, with published studies showing that it can be reliably used to inform clinical decisions with high levels of accuracy and have a positive impact on clinical decision-making.
Thirteen surgeons from across the UK have taken part in the study to date, recruiting the first 50 patients diagnosed with a cerebral aneurysm and scheduled to be treated via the minimally invasive placement of a small, flow-diverting stent into the affected blood vessel in order to minimise the risk of aneurysm rupture.
“It’s great to be part of this landmark trial,” said the study’s chief investigator Tufail Patankar (Leeds Teaching Hospital, Leeds, UK), speaking shortly after the first patient recruitment had been announced in August 2022. “It is so important that, as clinicians, we are able to access solid, independent evidence for new technologies like PreSize—but, as no one has done this before in the field of medical software, it feels like we are shaping the future and creating a new standard.”
Oxford Heartbeat states that, for each unique patient case, choosing the most appropriate device from the hundreds of available options is “challenging”—and suboptimal choices resulting from current planning methods can lead to device wastage and surgical inefficiencies, which could in turn result in serious patient complications. The company’s AI-powered PreSize software allows real-time, virtual rehearsals of treatment scenarios so that the clinical team can determine the optimal device before starting the procedure. The ongoing trial is comparing clinical decision-making between traditional methods without PreSize, and this more novel approach with PreSize.
When PreSize is used to support the selection of implantable devices, information is collected on surgical efficiency metrics—such as devices used in the procedure and duration of surgery—and, now that the study has reached its halfway point, the ICTU statistics team will be able to analyse the dataset.
According to Oxford Heartbeat, interim results on some of the main trial objectives will be presented and published in an effort to provide initial insights into the progress of the study thus far. Full dataset analyses and results will be presented when the trial concludes, the company adds.
“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,” Oxford Heartbeat’s recent release states.
PreSize Neurovascular received CE-mark certification as a Class I medical software under the Medical Device Directive (MDD) back in March 2020, meaning it had been deemed ready for market release at hospitals across the EU and UK.
