Project Summary

Problem to solve and market to address
The development of a painless colonoscopy platform with teleoperated robotic guidance, diagnosis and therapy for treating colonic pathologies in the early asymptomatic stage (e.g., CRC), is the target of the Project. Colorectal diseases and in particular CRC affects a large number of people worldwide, with a significant impact on public healthcare systems. CRC is forth in terms of incidence rate among all cancers in high–income countries, accounting for more than 1.400.000 new cases diagnosed and 700.000 deaths worldwide in 2012. The survival rate of CRC patients can reach 90% in case of early diagnosis falling down to less than 7% for patients with advanced disease. For this reason, regular screening is highly recommended for patients older than 50 years or who have family history of CRC. Making regular screening acceptable for people, easily performed by clinicians, and more accurate thanks to robotic technologies is what the Endoo aims to do. The industrial Partner expects a substantial market opportunity with an achievable market size for the Endoo product in the range of 600.000 procedures per year in 2025; this is a very conservative scenario, considering that at present, just in Italy, more than 480.000 colposcopies are performed every year. Further market growth attributable to increased adoption of the technique and technology evolution of the devices is expected afterwards. This leads to a market size of approximately 400 million EURO in 2028 (ten years after the end of the Project), which is considered achievable for the exploiters of the technology.

European priority
Endoo aims to improve the quality of life of a large number of European citizens (an asymptomatic and earlier stage diagnosis can save more that 65.000 European citizens per year), with a major impact on general health management and costs. Furthermore, the focused research efforts on robotic colonoscopy will enable closing the gap with USA and Asia concerning robotic colonoscopic techniques and establish Europe as the main actor and leading commercial player.

Current solutions
The standard technology behind flexible endoscopy basically consists of a long (approximately from 130 cm up to 160 cm), semirigid tube with a steerable head (diameter from 12 mm up to 14 mm). Steering cables pass through the shaft, making it relatively stiff compared with the compliant nature of the colon. The common way to introduce the instrument consists of pushing it into the colon while steering the tip to follow the lumen. As a result of this “back–wheel drive” approach, the shaft pushes against the colonic wall until the lumen and its surroundings provide sufficient counterpressure to force the shaft to bend. This manoeuvre stretches the colon and often leads to loop formation, thus causing substantial pain and discomfort for the patient (in most cases also perforation). In particular, looping occurs when the insertion tube continues to be advanced into the colon without corresponding progression of the distal tip, which displaces the colon from its native configuration and stretches mesentery muscles. Looping of the scope has been shown to be responsible for the vast of majority of pain episodes in colonoscopy and increases the chance of tissue damage and perforation. However, despite this colonoscopy is considered the most effective method for colorectal cancer diagnosis, colonoscopy take– up as a mass–screening procedure is limited mainly due to invasiveness, patient discomfort, fear of pain, and in some cases the need for sedation.

Why Endoo now
Currently, it is possible to observe a concrete convergence between: 1) a 20–year tradition in robotics and miniaturized devices for medical applications, emerging into well developed innovative colonoscopic devices and platforms, and effective and reliable medical techniques; 2) an ascertained implementation of computer–integrated methodologies and diagnosis enhancement algorithms for reconstruction / mapping in deformable environments; and 3) a mature development and implementation of control algorithms for robot interaction in unstructured environments and sensor, data and strategies fusion. On the side of the technology, 6 degree-of-freedom (DoFs) manipulators, miniaturized cameras, miniaturized sensors, and powerful computing hardware are available. On the side of scientific developments, several disciplines have matured significantly in the last ten years: real–time control and visual mapping, medical endoscope image processing, magnetic in–body navigation and medical miniaturized devices. Endoo aims to deliver a multidisciplinary research to bridge the gap in software and robot control to conceive a reliable colonoscopic platform with teleoperated robotic guidance, diagnosis and therapy for treating colonic pathologies, paving the way for a disruptive step in the field of robotic colonic inspection and treatment. The Endoo system has the potential, at this moment in time, to become now a real signature product and a life–saving platform.

Why Endoo with this Consortium
The objectives and impact of the Endoo proposal are very broad, concrete but ambitious, therefore their achievement requires a federated effort with European dimension and a strong Consortium with the complementary skills and track record. The Endoo Consortium is a unique blend of European pioneers in all the involved disciplines (i.e., robotics, information technologies, biomedical technologies, computer science and industrial development and exploitation), all of whom have internationally recognized leadership in their respective research fields, as well as the vision, the commitment and the capabilities to implement Endoo successfully in terms of innovation, industrial development, demonstrations and, ultimately, pre-clinical applications for clinical future deployment in medical scenarios.

Three European Projects involved SSSA and other partners in the past years, giving to the Endoo project initial know-how and scientific/technological background: