Tag Archive for: Devices and Advanced Therapies

Team’s hip replacement surgery invention is set to be world first

Technology which is the first of its kind in the world and could transform the future of hip replacement surgery is being pioneered by a team of experts in Cambridge.

They have just won a major award to further develop their breakthrough technology, which aims to make hip surgery more precise and deliver better and longer-lasting outcomes – which is good for patients and the NHS.

The National Institute for Health and Care Research (NIHR) has awarded a £1.4 million Invention for Innovation (i4i) Product Development Award to advance work on the team’s “smart” joint “trial liner”.

Thin and flexible sensors, based on novel microfluidic technology developed in the University of Cambridge’s (UoC’s) Department of Materials Science and Metallurgy, are embedded in the trial liner.

The sensors measure forces passing through the joint to help the surgeon assess and balance the soft tissues, which aids the accurate positioning of the implant.

Once measurements are complete using the wireless surgical aid, the surgeon marks the ideal position for the implant, removes the smart trial liner, and completes the operation.

An exploded view of the thin and flexible sensors and the “intelligent” trial liner for the breakthrough technology in hip replacement being developed at Cambridge

There are currently no technologies that can deliver such readings during an operation and in real-time, and instead surgeons “balance” the joint based on “feel” and anatomical landmarks.

This is despite over two million total hip replacements (THRs) being performed annually, with the number constantly rising due to increasing lifespans, says the team.

The patient demographic is also shifting towards the young, so implants need to withstand higher stresses, and last longer, to avoid spiralling into a vicious circle of revision surgery and higher rates of dissatisfaction.

Driving this clinical initiative is chief investigator Professor Vikas Khanduja (pictured below), who is also consultant orthopaedic surgeon at Cambridge University Hospitals and clinical and research lead of the Young Adult Hip Service.

The technology development is being overseen by UoC Professor of device materials, Prof. Sohini Kar-Narayan, together with UoC biophysicist and translational scientist, Dr Jehangir Cama, who is leading on translational and commercialisation activities. They are joined by Consultant clinical scientist and CUH head of clinical engineering, Prof. Paul White.

Prof. Kar-Narayan said: “It has been a truly exciting journey so far in designing and developing a novel force sensing technology in my lab with a fantastic and dedicated team, resulting in a prototype device that can potentially measure and help balance forces during total hip replacement surgeries.

“The team is really looking forward to this next phase of product development that will see us move towards an actual product that is fit for clinical use, and that has the potential to revolutionise joint replacement surgery.”

Dr Cama added: “We are delighted and extremely grateful to see our years of work rewarded with this major translational grant from NIHR. The funding will bring together wide-ranging expertise to help us further develop our prototype, thereby bringing this novel technology ever closer to clinical use.”

Also giving expert input are NIHR Cambridge Biomedical Research Centre science communication and patient/public engagement strategist, Dr Amanda Stranks, UoC’s Office for Translational Research, and commercialisation director of Cambridge Enterprise Limited, Dr Terry Parlett.

Professor Khanduja

The team currently has a prototype version of the device, which has been validated in the laboratory and in other tests. However, the NIHR award is pivotal in further developing and finalising the design and complying with regulations before it can be tested in a living patient.

Professor Khanduja, pictured left, who in 2021 was awarded the Hunterian Professor Award for innovative work, said: “We are incredibly grateful to the NIHR for this grant and extremely proud to have won it.

“It will fund a two-year project to help us collect the data needed to complete key product development milestones to further this technology’s path out of the lab and into the clinic.”

The team’s underlying sensor technology intellectual property has been protected via a patent application filed by Cambridge Enterprise, which lists Prof. Kar-Narayan, Mr Khanduja, and Dr Cama amongst its inventors.

Together with business partner and translational expert Dr Alex Samoshkin, they have also incorporated ‘ArtioSense Limited’ as the potential commercialisation vehicle for the technology.

Prof. Miles Parkes, director of the NIHR Cambridge Biomedical Research Centre said: “The project has strong support through our BRC’s new ‘Medical Device’ theme.

“It has the potential to deliver a sophisticated technical solution to a major clinical need and represents a complex collaboration between surgeons and Clinical Engineering Innovation at Addenbrooke’s Hospital, a local subcontractor, Springboard, which specialises in device development, the Department of Material Sciences and Metallurgy in the University of Cambridge and the Office for Translational Research.

“We are delighted to see it launching and wish the research team every success.”

Dr Terry Parlett, commercialisation director at Cambridge Enterprise, said: “The awarding of this grant will provide a tremendous boost to help bring this innovative technology from bench to bedside.

“This is a fantastic example of Cambridge’s entrepreneurial clinicians, academics and their institutions working together with forward-looking funders to create a positive impact for markets, society and importantly patients.”

Dr Silvana Cossins, NIHR i4i senior programme manager, said: “We are pleased to support this innovative project that aims to benefit patients undergoing hip replacements. We look forward to engaging with Mr Khanduja, Prof. Kar-Narayan, Dr Cama and the rest of the project team over the course of the award to make this project a success.”

The NIHR Invention for Innovation (i4i) Programme is a translational research funding scheme aimed at medical devices, in vitro diagnostic devices, and digital health technologies addressing an existing or emerging health or social care need.  More about it is available via this webpage.

ArtioSense have produced a video about this exciting technology: watch it here:

New trial brings screening for oesophageal cancer closer

A man from Cambridge is the first to join the surveillance part of a clinical trial part-funded by NIHR Cambridge BRC and supported by the NIHR Cambridge Clinical Research Facility, that could see routine screening for oesophageal cancer introduced into the NHS, potentially halving deaths from this cancer every year.

The capsule sponge, known as the pill-on-a-thread, is a quick and simple test for Barrett’s oesophagus, a condition that can be a precursor to cancer. Heartburn is a common symptom of Barrett’s oesophagus, a changing of cells in the food pipe.

The BEST4 trial launched at Addenbrooke’s today is the final step to see if the capsule sponge can prevent oesophageal cancer when used to screen or monitor those most at risk of the disease. If so, it could become a national screening programme across the NHS, in the same way mammograms are used to screen for breast cancer.

The first stage of the trial, BEST4 Surveillance, is for people already diagnosed with Barrett’s oesophagus. It will look at whether the capsule sponge test could replace endoscopies to monitor their condition. Participants will receive both examinations during the trial with results used to assess their risk of developing oesophageal cancer.

The second stage of the trial, BEST4 Screening, opens in the summer and will recruit 120,000 people aged over 55 on long-term treatment for heartburn.

The multi-million-pound trial is jointly funded by Cancer Research UK and the National Institute for Health and Care Research.

Tim Cowper, 49, a brewer from Cambridge (pictured), has had acid reflux, or heartburn, every night since he was 16. A routine health check while he was at university resulted in the shock diagnosis of Barrett’s oesophagus. After his diagnosis, he has been monitored ever since.

Tim said: “I was alarmed when I was told that having Barrett’s meant having pre-cancerous cells in my gullet. Cancer is never a nice word to hear, especially when you are so young, but luckily, I’ve had my condition monitored.

“Since my diagnosis, I’ve been going for an endoscopy at least once every three years to monitor my oesophagus. It is not pleasant at all. Each time I have a thick tube pushed down through my mouth and I can feel every single one of the biopsies taken by the camera. Swallowing a capsule sponge is a much better experience and I now get the test before my regular endoscopy appointment.”

The trial builds on decades of research led by Professor Rebecca Fitzgerald (pictured), a doctor and researcher at Addenbrooke’s and the University of Cambridge. She and a team of scientists, clinicians and nurses at the Early Cancer Institute, University of Cambridge and Cancer Research UK Cambridge Centre, invented and refined the capsule sponge test.

Prof Fitzgerald said: “The capsule sponge, a quick and simple test for Barrett’s oesophagus, could halve the number of deaths from oesophageal cancer every year. Cases of oesophageal cancer have increased six fold since the 1990s. On average only 12% of patients live more than five years after diagnosis. Most don’t realise there’s a problem until they have trouble swallowing. By then it is too late.

“The first phase of the trial looks at whether the capsule sponge can be used as a cancer early warning system for patients diagnosed with Barrett’s. Using the capsule sponge and a new set of lab tests, we will be monitoring patients to see if we can prevent more cases of cancer.”

Barrett’s oesophagus is currently identified via an endoscopy and a biopsy in hospital following a GP referral. It is time-consuming, unpleasant, and quite invasive for patients, as well as being expensive for the healthcare system.

The capsule sponge is a small, easy to swallow capsule on a thread, which contains a sponge. The patient swallows the capsule which dissolves in the stomach and the sponge expands to the size of a 50p coin.

The sponge is carefully pulled back up using the string, collecting cells for laboratory testing. The test takes just 10 minutes and can be done in a GP surgery.

Cancer Research UK and others have funded several successful clinical trials to demonstrate that the test is safe, accurate and can detect 10 times more cases of Barrett’s oesophagus than standard practice.

The test is faster and cheaper than endoscopy, which is currently used to diagnose and monitor Barrett’s oesophagus and oesophageal cancer. It has been piloted in health services in England, Scotland and Northern Ireland for patients who are currently on waiting lists for endoscopy because they have long-term heartburn or diagnosed with Barrett’s oesophagus.

Executive Director of Research and Innovation at Cancer Research UK, Dr Iain Foulkes, said: “Around 59% of all oesophageal cancer cases are preventable. Yet endoscopy, the gold standard for diagnosing and treating this cancer, is labour-intensive. We need better tools and tests to monitor people most at risk.

“Backed by funding from Cancer Research UK, the capsule sponge has become one of the most exciting early detection tools to emerge in recent years. It’s a remarkable invention by Professor Fitzgerald and her team, and previous trials have shown how powerful it can be in identifying cancer earlier.

“There are 9,200 people diagnosed with oesophageal cancer in the UK every year and the capsule sponge will mean they can benefit from kinder treatment options, if their cancer is caught at a much earlier stage.”

The future Cambridge Cancer Research Hospital will bring together clinical and research expertise, including Professor Fitzgerald’s work, under one roof. It will enable the development and discovery of more non-invasive devices like the capsule sponge, to detect cancer earlier, and save more lives.

Tim said: “I’m really lucky as my own condition hasn’t got worse and there are no signs of progression to full cancer. I take care with my diet to keep my acid reflux in check, but I can still have the odd curry and, most importantly, taste the beer I make!

“Taking part in this study means a lot to me. My condition was caught before it even became a fully-fledged cancer. Sadly, many others aren’t so lucky. The capsule sponge could help others whose acid reflux is causing something more sinister.”

The BEST4 Surveillance Trial is led from Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge, with trial design, coordination and analysis of results by the Cancer Research UK Cancer Prevention Trials Unit at Queen Mary University of London. More information about the BEST4 trial can be found at www.best4trial.org

Funding boost for ‘sponge on a string’ trial

Millions of pounds in funding has been announced for a trial that could pave the way for a ‘sponge on a string’ test to be established as a routine screening programme to detect Barrett’s oesophagus – a condition that can lead to oesophageal cancer.

Cancer Research UK and the National Institute for Health and Care Research (NIHR) are providing £6.4 million for testing of the Cytosponge-TFF3 pioneered by Professor Rebecca Fitzgerald and her team at the University of Cambridge.

The Cytosponge was created in Cambridge by Professor Fitzgerald back in 2001. Early trials were supported by the NIHR Cambridge BRC and NIHR Cambridge Clinical Research Facility, making sure the device was safe and accurate in detecting Barrett’s oesophagus.

Further studies then showed the Cytosponge detected 10 times more cases of Barrett’s oesophagus compared with routine GP care*.

The new trial, BEST4, will now explore if the Cytosponge can prevent deaths from oesophageal cancer when offered as a screening test to people on long-term medication for heartburn – one of the most common Barret’s oesophagus symptoms.

Researchers will also investigate if the Cytosponge, coupled with additional lab biomarker tests, can be used to monitor people already diagnosed with Barrett’s oesophagus instead of endoscopy, an invasive hospital procedure for which there is a major backlog caused by the pandemic.

It is anticipated the trial team will begin setting up sites in autumn, with 120,000 patients to take part over 14 years. Those involved will be randomised to different groups and a third of those will receive the Cytosponge, a quick and simple test that can be carried out by a GP.

Professor Fitzgerald will lead the trial alongside Professor Peter Sasieni and his team from King’s College London.

Professor Rebecca Fitzgerald

Professor Fitzgerald, pictured right, said: “The BEST4 trial is an exciting opportunity to take our work on the Cytosponge-TFF3 to the next level and see whether this test not only detects more cases, but also saves lives from cancer of the oesophagus. It will be a big piece of work, but it’s timely given the push from the NHS leadership, the Life Sciences Industrial Strategy and Cancer Research UK to detect cancers earlier in order to improve outcomes for patients.”

The Cytosponge begins as a pill on a string. It is swallowed by a patient and when it reaches the stomach the coating dissolves. This allows the pill to expand into a small sponge, about the size of a 50p coin. The sponge is pulled back out of the stomach by a nurse. As the sponge comes up it collects cells from the oesophagus for lab analysis.

Dr Iain Foulkes, executive director of research and innovation for Cancer Research UK, said: “Cancer Research UK is celebrating 120 years of life-saving discoveries this year and we’re really pleased to be funding what will hopefully be the final trial before this pioneering development is established as a screening device to detect Barrett’s oesophagus.

“There are 9,200 people diagnosed with oesophageal cancer in the UK every year and the Cytosponge will mean they can benefit from kinder treatment options if their cancer is caught at a much earlier stage, hopefully helping to boost survival rates at the same time.”

Using the Cytosponge during the pandemic

During the height of the pandemic patients were not being seen for routine gastroscopy. It was decided to rapidly implement use of the Cytosponge test because it has a low aerosol generation and needs only one person to carry out the procedure.

Irene Debiram-Beecham led on the implementation and at the Royal College of Nursing’s annual Nursing Awards she was highly commended in the Excellence in Cancer Research Nursing Award category. The award is sponsored by Cancer Research UK and the only one in the UK to recognise research nurses working on cancer trials and studies.

Irene, principal research nurse for the Cambridge ACED Clinic, said: “As part of this initiative, I provided a new robust training programme for nurses, clinicians and health care professionals across the UK. Having developed a system to sign them off as competent to carry out the procedure, I also provided a 24-hour support service for my colleagues if they had any questions.

“As a research nurse, it makes me proud to see something I’ve been working on for many years has finally made it into clinical practice.”

* Fitzgerald, R. C., et al. A pragmatic randomised, controlled trial of an offer of Cytosponge-TFF3 test compared with usual care to identify Barrett’s oesophagus in primary care. The Lancet, 2020

Adapted from CRUK press release

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