University Hospitals of Leicester NHS Trust (UHL) has transformed patient access to diagnostics for Barrett’s oesophagus, a risk factor for cancer, through the roll out of capsule sponge testing. The team’s creation of a new nurse-led diagnostic pathway has allowed them to cut gastroscopy waiting times, improve clinical capacity and deliver a better experience for both patients and clinical staff. 

Leicester’s pioneering capsule nurses bring capsule sponge testing to the community

Nurses at University Hospitals of Leicester NHS Trust (UHL) have transformed patient diagnosis of the condition, by moving the procedure out of the hospital setting.

The move has seen a 20-week reduction in patient waiting times and has gathered positive feedback from patients.

How the test works

The capsule sponge test is available to patients with symptoms of gastro-oesophageal reflux disease such as acid reflux or heartburn and is being offered as a less invasive alternative to endoscopy.

The procedure involves patients swallowing a small capsule-shaped device that contains a tiny sponge.

The sponge then expands in the stomach and collects cell samples for analysis as it is being extracted via an attached string.

It can be used to diagnose Barrett’s oesophagus, a condition where oesophageal cells grow abnormally, which can lead to cancer if undiagnosed.

Introducing the test to Leicester

The NHS began piloting the test across trusts during the pandemic, due to increased pressure on services and a growing backlog for endoscopy.

Findings from the pilot, published this year, revealed that thousands of patients had benefitted from the sponge on a string test.

Nurses – who often perform the procedure in hospitals – have now paved the way for it to be undertaken in the community too.

At UHL, specialist nurses had noticed that the trust was facing all-time high waits for gastroscopy and wanted to introduce the capsule sponge test out in the community to combat it.

Initially it was rolled out at St Luke’s Hospital in Market Harborough, and has since been extended to two further community hospital sites.

Capsule sponge nurse feedback

Colette Green, a community matron at the trust, told Nursing Times that when they initially began the rollout in the community, they were fitting it around their usual workload at the hospital.

“We didn’t get any extra time or funding when we originally started,” she explained.

“As with a lot of these things, sometimes you have to take a bit of a risk.”

Ms Green noted that the procedure was “better for patients and gets done a lot quicker” because there is no need for sedation.

In addition, she said it was a cost-saving procedure because it just requires one nurse and their equipment.

Creating a nurse-lead capsule sponge clinic

Following a funding injection, the trust decided to create a permanent nurse-led clinic to undertake the procedure across different community hospital sites.

The nurses now work within a 17-mile radius of the city to undertake the procedure.

Vanessa de Vivian, lead capsule sponge clinical nurse specialist at the trust, told Nursing Times that the pilot had provided her with the opportunity to be upskilled.

She noted that, in some cases, band 6 endoscopy nurses were “very limited” in where and how they could progress.

“I was looking at alternative employment and what I could do to specialise,” Ms de Vivian explained.

“Then we fell upon this, and it’s something that I am passionate about, and I’ve now gone from a band 6 to a band 7, leading the service and setting up a service – it is absolutely fantastic."

She added: “It’s nice to have the opportunity to actually work independently.

 “People have confidence in us as nurses, to allow us some scope to be able to do that.”

So far, the team has done the procedure on more than 560 patients and have received lots of positive feedback.

It has resulted in a 20-week reduction in patient waiting times, as well as making testing available to more sites across Leicester.

All patients who previously had other gastroscopy procedures said they would prefer to have a capsule sponge test in the future.

Meanwhile, 99% of patients said they experienced little to no discomfort during or after their capsule sponge test.

UHL has plans to expand the reach of the community-led sponge on a string test.

Expansion plans

Ms Green said the trust was looking to take on more band 6 nurses to carry out the procedure in the community.

“It frees up the clinicians and nurse endoscopists to concentrate on the more complex procedures and things that need to be done in an endoscopy room in an acute setting,” she explained.

Meanwhile, the trust is working to change the criteria for referrals from GPs so that they can directly refer patients to have the sponge on a string procedure.

The vision is that, in time, capsule sponge testing will be offered as a first-line diagnostic procedure for those with gastro-oesophageal reflux disease.

It comes as there are still many people in the community self-medicating for acid reflux who should be offered a test, explained Ms de Vivian.

“There’s many people undiagnosed with Barrett oesophagus,” she said.

“Obviously we know in the medical field that that can lead to oesophageal cancer.”

Separately, Ms de Vivian noted that other hospital trusts had taken an interest in UHL’s work.

She said that she had so far attended meetings with six nearby hospital trusts to see how the procedure could be replicated at other organisations.

Ms de Vivian said: “I think it’s really good if you get nurses with a passion who are already doing [gastroscopy].

“I believe in it, and I think it should be [rolled out] across the UK.”

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Read the article 

The Summer edition of Gastroenterology Today features two articles that demonstrate how capsule sponge testing can improve the clinical capacity of endoscopy teams.

Read the summary below or see the full publication on the Gastroenterology Today website.

Leicester Case Study

‍The Challenge

University Hospitals of Leicester NHS Trust (UHL) has transformed patient access to diagnostics for Barrett’s oesophagus through the roll out of a nurse-led capsule sponge testing pathway. Implementing capsule sponge testing has allowed them to cut gastroscopy waiting times, improve clinical capacity and deliver a better experience for both patients and clinical staff.

The team at UHL had an ambition to reduce wait times and improve survival chances for a lesser-known group of patients with Barrett’s oesophagus that affects around 1 million adults in Britain. However, the team were facing all-time high waits for gastroscopy and saturated 2-week wait pathways, placing these patients at increased risk of late diagnosis.

● Average patient wait time for this group: 6-12 months

● Number of staff able to perform the initial diagnostic test: 1

● Number of locations the initial diagnostic test was available from: 1

The Solution

Testing was undertaken by a range of clinical professionals from nurses to consultants – widening the possible delivery of the service - which provided the potential to reduce the wait associated with traditional endoscopist-led endoscopy procedures. The team also improved their triaging process for the test, adding electronic forms to improve the speed and accuracy of patient selection. Capsule sponge testing offered the opportunity for nurses to be upskilled, providing improved career pathways which the team felt would strengthen both their attraction and retention. By improving their capacity to deliver the service, and upskilling their team, the Trust was able to create a nurse-led clinic that could see more Barrett’s patients, more quickly.

“What started as two nurses with an idea has become a key part of our pathway and now my full time job! The training opportunity alone has helped position ourselves as an innovative service that people are excited to join. Our staff retention has improved and we’re already hiring for more as we plan to roll out capsule sponge testing for other patient groups, and look to GP referrals to reach even more people. Our vision is that in time, all patients for Barrett’s surveillance and investigation for GORD will be offered capsule sponge testing as a first line diagnostic procedure.” Vanessa deVivian, Capsule Sponge Lead Nurse Specialist

Key Findings

● 20 week reduction in patient waiting times.

● Increased capacity, with 3 staff able to perform the test. One dedicated full-time nurse and two other part-time.

● Testing now available to more sites across the Trust and expanding into community care.

● The early detection of Barrett’s oesophagus has helped to prevent the occurrence of oesophageal cancers.

● Positive impact on staff retention and acquisition, with colleagues expressing how valued they feel.

● Cost reduction of around 50% compared with gastroscopy, due to the different skill mix, setting and product.

The Trust’s nurse-led model demonstrates a clear way for other services to reduce the pressure on endoscopy teams, while still offering exciting training opportunities and autonomy to those that want to innovate. By expanding the deliverability of the testing, UHL is leading the way in developing cost-effective, nurse-led services that can provide better access, experience, and outcomes for patients.

For further details, or to discuss how Cyted Health can support your service in creating a capsule sponge pathway, please get in touch.

Managed Service Support

For Trusts that want to take advantage of the capacity boost that capsule sponge offers, but need extra workforce support, managed services company Xyla has put forward an example patient pathway featuring their insourced.

Read the full article here.

Cyted Health today announces the appointment of Betsy Hanna as US President, where she will lead the company’s expansion into the US market. Betsy joins the company at a pivotal time, following FDA clearance for Cyted Health’s EndoSign® device earlier this year.

Betsy brings more than 20 years of healthcare executive leadership experience for diagnostics and medical device companies including genomic testing in oncology. She has a track record of leading strategy, marketing, and commercialization in global businesses and innovative start-up companies, successfully launching new products in the US and beyond. Betsy previously served as Agendia Precision Oncology’s Chief Commercial Officer and Executive Vice President. She received her MBA at Harvard Business School and holds a degree in Chemical Engineering from the University of Illinois.

“Betsy joins us to take on the significant work already underway to bring our products to the US market,” said Dr Marcel Gehrung, Cyted Health’s CEO and Co-Founder. “This is a crucial moment in what will be a core market for Cyted Health’s work, and Betsy will bring deep expertise and considerable experience to grow our presence in the US. She will be invaluable for guiding our team through successful commercialization and her appointment is another step to expanding our footprint globally.”

The FDA’s clearance of EndoSign® in February was one of a series of recent milestones achieved by Cyted Health in the US. It followed a partnership with Devyser Genomic Laboratories to conduct the lab analyses announced in January. In November last year, Gail Marcus was appointed Chair of the Board, bringing her vast knowledge of the US healthcare system and supporting Betsy to deliver this year’s strategic plan.

Cyted Health is a gastrointestinal health company that has developed EndoSign®, a minimally invasive test to detect and monitor for signs of pre-cancer and other diseases. Testing can be completed in minutes in a nurse-led clinic. EndoSign® is already widely used across the UK to identify Barrett’s esophagus – a precursor to esophageal cancer – and the risk of patients developing cancer in the future.

“I look forward to leading Cyted Health’s US arm and contributing to the fight against esophageal cancer,” said Betsy Hanna. “EndoSign® can transform current methods for monitoring patients and make sure conditions are detected earlier and treated faster. I am highly confident that we can make a significant impact bringing this technology to US patients.”

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Read the full case study here.

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The national implementation of capsule sponge testing in Scotland has delivered significant improvements for the care of upper gastrointestinal patients. The testing programme launched in 2020 to improve the quality of care and diagnostic waiting times for patients with Barrett’s oesophagus and those at risk of oesophageal cancer.

The challenge

The onset of the COVID-19 pandemic interrupted Scotland’s endoscopy services, resulting in insufficient capacity to deliver timely procedures for patients requiring surveillance for Barrett’s oesophagus. Delays to surveillance increase the risk of cancer progression being missed until the later stages. This prompted the search for non-endoscopic options with strong clinical evidence, with NHS Scotland opting to use the capsule sponge test.

The solution

During the pandemic NHS Scotland began the national-level implementation of capsule sponge testing, to find a way to fast-track patients with signs of cancer for treatment and schedule patients at medium-to-low risk for their next surveillance procedure appropriately. As of January 2024, over 6000 tests have been performed throughout Scotland, with the test acting as a triage tool to identify patients requiring further investigation with endoscopy.

Key findings

Capsule sponge testing has cut patient waiting times significantly for NHS Scotland, while enriching endoscopy lists and boosting dysplasia detection rates to help clinicians identify more at-risk patients. This has released endoscopy resources for other complex procedures, such as bowel cancer screening.

• Using the test for screening has helped Scotland reduce the demand for follow up endoscopies by 77%.
• A national evaluation predicted cost savings of £700k in the first year and £3.3m over 5 years.
• NHS Scotland reduced median waiting times for endoscopy from 9 months to 5 months.
• From under 10% to over 50% concerning pathologies found at endoscopy.

Conclusion

By delivering high-quality care with fewer endoscopies, NHS Scotland has demonstrated what state-of-the-art Barrett’s surveillance could look like, prompting clinical teams across the UK and Europe to consider how to make a difference in the earlier detection of oesophageal cancer.

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• Cyted and Microsoft Research collaborated to build novel AI models for efficient screening of cancer cells that could reduce pathologist workload by as much as 63%
• Nature Communications published an article detailing the research

Cambridge based health company Cyted announced a publication in Nature Communications on research conducted in collaboration with Microsoft Research developing machine learning tools to enable earlier and faster detection of Barrett’s esophagus, a precursor to cancer.

“We have been delighted to collaborate with Microsoft Research to push the boundaries of what’s possible in medical imaging and screening technologies, creating optimal efficiencies from start to finish of the testing process” said Dr Marcel Gehrung, CEO and Co-founder at Cyted. “As we continue to expand, machine-learning will be an important tool to support our goals and make early cancer detection more accessible."

Esophageal cancer is one of the deadliest cancers with a five-year survival rate of less than 15%. Detecting Barrett’s esophagus, a precancerous condition, helps identify patients who are at a higher risk of developing esophageal cancer. Monitoring patients with this condition offers the best chance of early cancer detection and therefore earlier treatment of esophageal cancer, dramatically improving survival rates to 9 in 10 people surviving after 5 years.

The article titled “Enabling large-scale screening of Barrett’s esophagus using weakly supervised deep learning in histopathology” is an example of the innovative research that Cyted and Microsoft Research are advancing to optimize clinical workflows and improve the capabilities of earlier identification of cancer with technology.

Cyted’s capsule sponge technology, EndoSign® is a non-endoscopic test that collects cells from the esophagus in a process that takes less than ten minutes. Analysis of these cells is conducted by pathologists to identify biomarkers - a measurable biological indicator of the likelihood of a cancer developing.

Artificial Intelligence is being used to optimize the screening process by leveraging machine learning to help triage the large sets of pathology images. This saves precious pathologist time by screening out negative cases and controlling the quality of digitalized samples, cutting the pathologist’s workload down by as much as 63%.

“Microsoft Research seeks to advance science and technology to benefit humanity, often by identifying new applications for leveraging AI and machine learning,” said Javier Alvarez-Valle, Senior Director of Biomedical Imaging at Microsoft Research. “Collaborating with Cyted and sharing our work via open source will empower researchers and clinicians around the world to leverage this technology in their fight against cancer.”

The full article in Nature Communications can be viewed here.

A blog post written by Microsoft Research can also be found here.

• Capsule sponge technology proven to alleviate resource pressure on delivering endoscopies by reducing demand in secondary care by 78% in the UK
• IQVIA calculated expected savings for the UK National Health Service of an estimated £421 per patient

An independent assessment by advanced analytics provider IQVIA in partnership with NHS England has found that Cyted’s minimally-invasive diagnostic technology reduced the demand for endoscopies in secondary care by 78%, improved the patient experience and decreased costs for the UK health system.

“The findings of this report illustrate the significant national impact of embedding our capsule sponge technology,” said Cyted CEO and Co-founder Marcel Gehrung. “It has allowed patients waiting for endoscopy to be effectively prioritised, enabling those in urgent need of diagnosis to be tested more quickly, reducing waiting lists and decreasing pressure on health systems. We look forward to expanding the adoption of this technology, helping detect disease earlier and improve patient outcomes.”

Cyted’s capsule sponge technology, EndoSign® is a non-endoscopic test used in the Heartburn Health Check. It sees patients swallow a capsule which collects cells from the oesophagus in a process that takes less than ten minutes. Analysis of these cells allows clinicians to monitor patients suffering from chronic heartburn and Barrett’s oesophagus - conditions that bring a higher risk of developing oesophageal cancer - and ensure that cancer is quickly detected and treated.

IQVIA’s report found that patient satisfaction levels were high, with 82% of patients agreeing that they were satisfied with their experience. Patients who had received an endoscopy before explained that the capsule sponge test was a preferable option to the current standard of care for diagnosing and monitoring patients with Barrett’s oesophagus. Wider deployment of the technology would serve to help improve patient experiences, alongside reducing waiting lists and easing pressures on patient pathways.

In reducing the number of endoscopies, this technology also reduced costs to the health system and alleviated the resource pressure in delivering endoscopy. The inclusion of capsule sponge technology in the diagnostic pathway resulted in a cost-saving of at least £421 per patient. Overall, according to IQVIA’s report, the introduction of the test at a national level would generate cost savings of up to £33 million over the course of five years for the NHS.

Swift diagnosis of Barrett’s oesophagus helps to identify more cancers earlier and faster. Oesophageal cancer is one of the most aggressive cancers, with over half a million people dying from the condition globally every year. By improving the efficiency and providing pre-screening capabilities, the capsule sponge technology of EndoSign® can help patients at risk of Oesophageal cancer. There are currently over 60 hospitals and 15 GP-based clinics offering EndoSign® testing across England, Scotland, and Wales.

Amanda Pritchard, NHS England’s chief executive, said: “Thousands of people have now benefited from this incredibly efficient test on the NHS. While the sponge on a string is small in size, it can make a big difference for patients.”

The project was undertaken by IQVIA over the course of the last two years in collaboration with National Health Service teams, Cyted, Medtronic, Cancer Alliances, Cambridge University and ENDOPREM.

Full press release from NHS England available here

A recording of the BSG webinar is available here

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Health company Cyted announces that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its EndoSign® cell collection device, which is a non-endoscopic capsule sponge device used to collect pan-esophageal samples. These samples are then sent for laboratory testing to detect esophageal pre-cancer and other conditions.

Marcel Gehrung, CEO and Co-founder of Cyted, expresses the importance of the milestone, stating “This clearance opens up significant opportunities for Cyted across new geographies and health systems and confirms our device is safe and effective for use in the US. Combined with novel biomarkers, Cyted’s potential to transform the way patients with chronic reflux are identified and monitored is significant and this clearance is a major step for our expansion.”

Effective immediately, this 510(k) FDA clearance is an exciting step to bringing the Heartburn Health Check with EndoSign®, into new markets. Commercialization plans are already underway facilitated by a new partnership with Devyser Genomic Laboratories announced earlier this month.

Cyted’s Chair and non-executive director Gail Marcus said “Building on their achievements in the United Kingdom, Cyted’s FDA clearance marks an exciting milestone for the global business. We are excited to continue to empower patients by providing innovative solutions for diagnosing gastrointestinal diseases.”

Gail Marcus, appointed as Chair of the Board in November, will be supporting Cyted’s expansion into the US. The EndoSign® technology is already widely used across all regions in the United Kingdom as part of the Heartburn Health Check which investigates patients with symptoms such as persistent heartburn and reflux to identify those at risk of developing esophageal cancer. Gail’s deep expertise in the US healthcare system will be vital to realizing Cyted’s potential in the US.

“The current paradigm of endoscopy-based screening to prevent esophageal cancer has not decreased the incidence of this deadly disease. Non-endoscopic screening offers a promising, cost-effective new direction to decrease cancer deaths. I am pleased that new modalities such as EndoSign® will be available for our patients.” said Nicholas J. Shaheen MD, MPH, Professor of Medicine and Chief of the Division of Gastroenterology and Hepatology at the University of North Carolina School of Medicine.

The EndoSign® technology has already demonstrated significant impact across multiple indications and applications in the digestive tract. Cyted has recently received a $1.3 million grant from the UK government to launch a precision medicine project for the diagnosis and treatment response prediction for the condition of Eosinophilic Esophagitis (EoE).

Cyted's carbon reduction plan can be viewed here

The BEST4 trial, designed to evaluate the potential of a national screening programme, started today. It seeks to explore if our Heartburn Health Check using the minimally invasive test, EndoSign, can prevent deaths from esophageal cancer when offered as a screening test to people on long-term medication for heartburn.

“This is another major step forward for our technology. The trial will evaluate the potential for a national screening programme and explore if our Heartburn Health Check using the minimally invasive test, EndoSign, can be used to prevent esophageal cancer when offered as a screening test to people on long-term medication for heartburn” said Cyted’s CEO and co-founder, Marcel Gehrung, “Our test is already deployed in over 70 hospitals and GP surgeries all across the UK and demonstrates how innovation can have a real and lasting impact on our health system, reducing waiting lists and ultimately saving lives.”

With Cyted’s non-invasive capsule sponge test continuing to prove its effectiveness at diagnosing Barret’s esophagus in the UK, the trial could pave the way for a test to be established as a routine screening programme to detect the condition, which can lead to esophageal cancer.

The trial builds on decades of research led by the Director at the Early Cancer Institute and Cyted’s co-founder, Professor Rebecca Fitzgerald. She and the team at Cyted invented and refined the capsule sponge test.

Tim Cowper, 49, a brewer from Cambridge, 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 esophagus. 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 esophagus. 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 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.

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