Technology-Led Clinical Trials
Technologies and novel techniques for diagnosis and treatment developed with the Institute and in collaboration with industrial partners are continuously entering clinical trials. Our researchers are not only involved in the discovery, prototyping and development of new technologies, but also receive training and work with clinical colleagues to understand the human factors involved in their clinical deployment and drive their adoption. Working with the University of Oxford registered clinical trials unit, our portfolio and expertise ranges from diagnostic and predictive techniques involving Big Data, wearable devices and mobile phones, to Class II and Class III medical devices for diagnosis and therapy and combination products involving both a device and a drug.
PanDox: Targeted delivery of thermosensitive liposomal doxorubicin triggered by focused ultrasound in patients with pancreatic cancer
The PanDox clinical trial aims to demonstrate for the first time in patients that chemotherapy can be targeted and delivered more effectively to pancreatic tumours using focused ultrasound. This investigator-led study sponsored by the University of Oxford and supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre has now received ethics, MHRA and institutional R&D approval to commence (ClinicalTrials.gov Identifier: NCT04852367).
PULsE-AI for predicting arterial fibrillation using GP data
The "PULsE-AI" project is a screening tool that is implemented within Primary Care computer systems, which uses routinely-acquired data from GPs to predict the risk of future heart arrhythmia (atrial fibrillation, or AF). One of the greatest risk factors for stroke is untreated AF, but it is very difficult to identify this condition without relatively invasive equipment. This project, developed with Pfizer and Bristol-Myers Squibb, offers a step-change in our ability to screen patients for AF, without using anything other than the standard data that are recorded by GPs when one visits for a health check. This work has been fast-tracked through Randomised Controlled Trials and subsequent "health economics" trials, and is now in the process of final implementation within GP computer systems ( (ClinicalTrials.gov Identifier: NCT04045639).
MORPHEUS: Manipulating and Optimising Brain Rhythms for Enhancement of Sleep
The aim of this feasibility study is to investigate whether we can improve sleep quality in patients with deep brain stimulators by delivering targeted stimulation patterns during specific stages of sleep. We will examine the structure and quality of sleep as well as how alert patients are when they wake up, while also monitoring physiological markers such as heart rate and blood pressure. Upon awakening, we will ask the patients to provide their subjective opinion of their sleep and complete some simple tests to see how alert they are compared to baseline condition which would be either stimulation at the standard clinical setting or no stimulation. We hope that our study will open new ways of optimising sleep without the use of drugs, in patients who are implanted with depth electrodes. We also believe that our findings will broaden the understanding of how the activity of deep brain areas influences sleep and alertness ClinicalTrials.gov Identifier: NCT05011773).
Prolonged preservation and assessment of kidneys for transplantation
Almost 5000 patients in the UK remain on the NHS waiting list for a kidney transplant because of a persistent shortage of suitable donor organs. Unlike conventional cold storage, normothermic machine perfusion places the organ in an environment that closely resembles that of the body: blood, oxygen and nutrition are provided at normal body temperature (37 C), to allow the kidney to recover from the process of donation, avoiding the progressive injury that occurs if the organ is stored on ice. Also, because the kidney is functioning during preservation, it is possible to test its viability before the transplant. In partnership with OrganOx Ltd, we have built a normothermic kidney perfusion machine capable of 24 hours of preservation are now ready to test this new technology in 36 patients undergoing kidney transplants at the Oxford Transplant Centre. This trial is primarily designed to test the safety and feasibility of the new technology. It will also provide some evidence regarding effectiveness, to enable a larger randomised trial that will test efficacy formally.