Sonopill: minimally invasive gastrointestinal diagnosis and therapy

Capsule endoscopy for medical diagnosis in the gastrointestinal (GI) tract has emerged only in the past 10 years. Now established in "pillcams", which have benefitted more than 1 m patients worldwide, it is a clear candidate for further innovation.

Most capsule endoscopy devices record and transmit video data representing the visual appearance of the inside of the gut, but work has begun on other diagnostic techniques, such as the measurement of pH, and there has been some research into the use of capsules for treatment as well.

Medical ultrasound imaging is a safe, inexpensive technique which can be applied in real-time at the point of care. Ultrasound is also capable of treatment through focused ultrasound surgery and, in research, for targeted drug delivery.

The core of the Sonopill programme is the exploration of ultrasound imaging and therapeutic capabilities deployed in capsule format. This will be supported by extensive pre-clinical work to demonstrate the complementary nature of ultrasound and visual imaging, along with studies of multimodal diagnosis and therapy, and of mechanisms to control the motion of the Sonopill as it travels through the GI tract.

This brings research challenges and opportunities in areas including ultrasound device and systems design, microengineering and microelectronic packaging, autonomous capsule positioning, sensor suites for diagnosis and intervention, and routes to translation into clinical practice.

Our carefully structured but open-ended approach maximises the possibility to meet these research challenges while delivering for the UK a sustainable international lead in multimodality capsule endoscopy, to provide greater capabilities for the clinician, more acceptable practice for the patient population, and lower costs for economic wellbeing.

The gastrointestinal (GI) tract is subject to many different diseases. Some of these are described collectively as inflammatory bowel disease (IBD), notably including Crohn's disease and ulcerative colitis. Others relate to the reaction of the bowel to food, such as Coeliac disease, or to difficult physiological issues such as small bowel motility. Finally, cancer is a major issue, with oesophageal, stomach and colorectal cancers collectively forming more than 20% of all cases of cancer worldwide, and even cancer of the small bowel, a less common form, affecting more than 1 in 500 people in North America. These diseases are the target for Sonopill and the GI tract is its domain.

Sonopill will impact GI tract disease in three ways. First, it will provide a new means of diagnosis, including for early tissue dysplasia. Endoscopic ultrasound has been highlighted as a major innovation in endoscopy. Through the application of high resolution ultrasound (HRUS), the Sonopill will represent just as large a step forward in diagnosis from the present optical pillcams, themselves a revolutionary development in difficult diagnoses. Second, it will provide a new means of treatment. Using high intensity focused ultrasound (HIFU) for localised focused ultrasound surgery (FUS) and ultrasound-mediated targeted drug delivery (TDD), and with the potential for other means of hyperthermia such as microwave ablation, it will offer the GI consultant new therapeutic possibilities. Third, it will provide a means to further research in the GI tract, allowing repeated observation in a way that is presently impossible because of the invasive nature of conventional endoscopy and colonoscopy, and difficulty in passing enteroscopes through the entirety of the GI tract.

To realise clinical impact, Sonopill must reach commercial reality. To that end, we have partnered with a dozen companies covering the complete spectrum of Sonopill research and production, from virtual prototyping (Weidlinger Associates) through MEMS fabrication (Semefab) to testing (Precision Acoustics) and access to clinical practice (Karl Storz Endoskope). These companies will join an Industrial Impact Group (IIG) to ensure we keep in mind commercial constraints. Highly experienced senior figures from industry and universities have also agreed to join our International Advisory Committee (IAC), such as Dr Dalmolin (SORIN), Prof. Rau (Aachen), Dr McLaughlin (Zonare Medical Systems) and Prof. ter Haar (Institute of Cancer Research), and these will be complemented by a Local Clinical Committee (LCC).

In reaching commercial reality, Sonopill will also have economic impact, as the technology emerging from the research is productionised, then realised in mass production. There will also be a significant economic impact in the NHS and other healthcare systems from the reduced costs of diagnosis and treatment. For example, whilst the present £500 cost of an existing pillcam is not dissimilar to the cost of a straightforward gastroscopy, even this relatively simple device leads to much quicker diagnosis of difficult cases, saving the cost of multiple gastroscopies and visits to the clinic. This will, in turn, have an impact on society, as diagnosis and treatment become easier and therefore intrude less into the everyday life of the patient. Sonopill will also impact people and skills, directly by providing challenging training and scientific and engineering research for its cohort of early stage researchers (ESRs), and indirectly through advocacy for science and engineering which will contribute to engagement of the general population with subjects within the science, technology, engineering and maths (STEM) subjects.