First Patient Recruited in Clinical Impact Trial of PreSize® Neurovascular
Leeds, 15 August 2022 – Oxford Heartbeat is excited to share that its clinical impact trial of software PreSize® Neurovascular has recruited the first patient. The first-of-its-kind trial for decision-support software in the field of neurovascular interventions is independently run by Imperial Clinical Trials Unit (ICTU). Rather than being for regulatory clearance, which has already been achieved for PreSize, the purpose of this trial is to evaluate the benefits of PreSize’s use in clinical practice.
Funded by the UK’s National Institute for Health and Care Research’s (NIHR) prestigious AI in Health and Care Award, which was presented to Oxford Heartbeat by the UK’s Minister of Health, the trial is set to recruit 100 participants from 10 centres across the UK. Recruitment of the first patient marks a significant milestone towards setting a new international standard of clinical evidence generation for AI and medical software.
Dr Katerina Spranger, the founder and CEO of Oxford Heartbeat, expressed that “this is a key milestone for us and I am thankful for the support we have received”. Dr Spranger went on to explain that, “what we are doing in this trial has never been done before, so there have been some challenges, but the recruitment of the first patient marks a big step forward for us, and we are really excited to see how the trial progresses”.
PreSize aids clinical decision making for minimally invasive treatment of cerebral aneurysms with implant devices. Choosing the best-fit device for each unique patient (from hundreds of device options available) with the millimetre precision required for brain surgery is extremely difficult, and suboptimal choices from traditional planning methods can lead to complications. PreSize has been designed to allow real-time virtual rehearsal of scenarios at the point of treatment, so the clinical team can determine the optimal device before starting a procedure.
During the trial, which is registered and has received ethical and health research approvals, clinical decision making with and without PreSize will be compared for 100 prospective patients undergoing minimally invasive brain aneurysm surgery. Information on surgical efficiency metrics (such as devices used in the procedure and duration of surgery) will also be collected. This will provide objective and transparent evaluation of the benefits of PreSize’s use in clinical practice.
Previously published evidence has shown that PreSize can be reliably used to inform clinical decisions with high levels of accuracy and can positively impact clinical decision making. This evidence led to the software gaining CE-mark status. Oxford Heartbeat strongly believes that regulatory approval is not the end of the line, and is devoted to thorough and continuous evidence generation. For software as a medical device, it is important to continue evidence generation, even after regulatory approval is achieved, to objectively monitor the evolving impact and value of the software, and reveal areas for improvement.
This continuous need for evidence was highlighted by the study’s Chief Investigator Professor Tufail Patankar from Leeds Teaching Hospital, who was involved in the first patient recruitment: “It’s great to be part of this landmark trial. 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 would like to attribute the success of the trial so far to the collaborative work of the many individuals and partners involved, including participating clinicians and centres, ICTU and the NIHR. The first patient is the first step in the continual process of evidence generation, and the trial will go on to recruit more patients, with interim results published when the halfway point is reached.
Note to editors
