PreSize® trial receives ethics and compliance approval

Oxford Heartbeat secures ethics and HRA approval to commence clinical trials and test effectiveness of its CE-marked medical software Presize® Neurovascular in real-world clinical settings.


  • Ethics and compliance approval has been granted by Health Research Authority (HRA) to Oxford Heartbeat to run a prospective trial within the NHS

  • This approval is an essential stepping stone for the proper conduct of research within the NHS

  • The trial will now shortly commence across 9+ Trusts across the country, run by Imperial Clinical Trials Unit (ICTU)

 


 

London, November 2021 – Oxford Heartbeat today announced that it has secured ethics and HRA approval to commence a clinical trial study, testing the effectiveness of its CE-marked medical software for pre-operative rehearsals of neurovascular stenting procedures, PreSize® Neurovascular, in real-world clinical practice. 

 

Conducting a well-designed study to evaluate the clinical impact of our software in real clinical practice has always been in our plans; this is the gold standard in medicine. Getting the green light from the research authorities marks a big milestone for us, but also sets a case study for other digital health/AI companies on a similar journey since there are not many similar trial examples out there,” said Dr Katerina Spranger, CEO of Oxford Heartbeat.

 

Oxford Heartbeat is the proud recipient of the UK government’s AI in Health and Care Award (from NIHR and NHSx), which is funding this study. It will investigate how the PreSize® technology could change and impact the way clinicians plan and make decisions for  high-risk brain surgeries. So far 9 Trusts across England and Scotland have been recruited and the number is expected to increase to 10 by the end of the year; ultimately, anonymised information from 100 such surgeries will be collected for the study’s investigation. 

 

“It’s great to see an AI solution tailored to decrease preoperative stress and improve care – I’m looking forward to participating in the prospective study that will see the use of PreSize® software in our practice and evaluate its impact,” said Professor Tufail Patankar of Leeds Teaching Hospitals, Chief Investigator for the trial, who conducted the first virtual procedure rehearsal and planning in the NHS using the PreSize® software technology last summer, featured by The Times.

 

Obtaining HRA approval is a key requirement for the appropriate and ethical conduct of all project-based research involving the NHS, bringing together the HRA’s assessment of governance and legal compliance with the independent ethical opinion by a Research Ethics Committee (REC). To ensure objectivity and impartiality in the trial’s conduct, Imperial Clinical Trials Unit (ICTU) is running the trial and is responsible for the trial’s data analysis. 

 

The trial represents the next step for Oxford Heartbeat in its commitment to help the NHS fulfill one of their key long term goals – to deliver world-class care for major health problems including heart diseases and strokes – by providing transparent and objective clinical evidence about the software’s impact on clinical practice. A successful trial would affirm Oxford Heartbeat’s status as one of the most innovative digital health companies in the field.

 

-ENDS-

 

Note to Editors:

 

About Oxford Heartbeat

 

Oxford Heartbeat’s vision is a world where every patient and doctor is supported by the most advanced technologies, and successful surgical outcomes are the norm, not the exception. We are transforming this vision into reality by providing clinicians with the cutting-edge technology they need to make life-saving decisions in preparing and executing high-risk surgeries. We strive to be innovative, rigorous, transparent and caring, putting clinicians and patients at the heart of everything we do.

 

About PreSize® Neurovascular


PreSize® Neurovascular helps interventional neuroradiologists (INRs) to prepare for minimally invasive brain stenting procedures. High levels of risk and inadequate technologies currently used in these surgeries mean that stents are fitted in the patients’ anatomies based on a large amount of guesswork. PreSize® was designed to rectify these problems and help clinicians better prepare and execute surgeries in a more accurate way. INRs import patient scans into PreSize® and position the stent into the reconstructed virtual blood vessel model. PreSize® generates a best-fit stent given patient anatomy, and INRs can explore different stent sizes/makes in a safe virtual setting, making adjustments to their satisfaction before operating. Thus the best-fit stent is selected the first time round, reducing surgical complications and improving patient outcomes.