Endoscopic Versatile robotic guidancE, diagnoSis and theraPy of magnetic-driven soft-tethered endoluminAl robots
European Community's European Community's Horizon 2020 Framework Programme
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The Endoo project (Endoscopic Versatile robotic guidancE, diagnoSis and theraPy of magnetic-driven soft-tethered endoluminAl robots) aims at developing an integrated robotic platform for the navigation of a soft-tethered colonoscope capable of performing painless diagnosis and treatment.
Colorectal cancer is one of the major causes of mortality but survival rate dramatically increase in case of early diagnosis. Current screening colonoscopy is limited due to a variety of factors including invasiveness, patient discomfort, fear of pain, and the need for sedation; these factors consistently limit the pervasiveness of mass screening campaigns.
Built around a novel robotic colonoscope and designed to make its use straightforward for the endoscopist and ideal for mass screening, the Endoo system has the potential to introduce in the clinical practice a disruptive new paradigm for painless colonoscopy. Endoo combines a “front-wheel” magnetic–driven approach for active and smooth navigation with diagnostic and therapeutic capabilities for overcoming the limitations of current colonoscopy in terms of patient discomfort, dependence on operator skills, costs and outcomes for the healthcare systems.
The acceptance and consolidation of robotics in the medical domain and the ever–growing development of endoscopic–driven technologies are the fundamental building blocks for the realization of the Endoo platform which can take advantage of solid and IPR protected technologies provided by the Project Partners. Aim of the Endoo Project is to bring the system to the market for an extensive clinical use.
The Endoo Consortium is a unique blend of internationally recognized European pioneers (in all the involved disciplines), which will guarantee a dramatic leap forward in the current technology through successful implementation in terms of scientific innovation, industrial engineering, certification, market analysis, and ultimately clinical deployment.
Cancer is the leading cause of death (around 13% of all deaths) worldwide, accounting for 7.6 million deaths in 2008. Moreover, death from cancer is projected rise to over 13 million in 2030. Colorectal diseases and in particular colorectal cancer (CRC) affect a large number of people worldwide, with a dramatic impact on healthcare systems. CRC is fourth in terms of incidence rate among all cancers in high–income countries, accounting for 700.000 deaths worldwide in 2012. Nevertheless, the survival rate of CRC patients can reach 90% when diagnosis is made at an early stage (diagnosis at an asymptomatic stage can save more that 65.000 European citizen per year) falling to – for patients with advanced disease – less than 7%. For this reason, regular screening is highly recommended for patients older than 50 years or for those with a family history of CRC. However, CRC screening can be life–saving only if accuracy and reliability of the screening pathway is high at every step; screening is performed on predominantly healthy individuals, thus tests should be as non–invasive as possible so that the take up is maximal and a convenient trade–off between benefit and harm is maintained.
To date, conventional colonoscopy is considered to be the most effective method for CRC diagnosis and it represents the gold standard for the evaluation of colonic disease due to its ability to visualize the inner surface of the colon, acquiring biopsies, and treating some lesions as soon as they are detected. However, take–up of screening colonoscopy is limited due to a variety of factors including invasiveness, patient discomfort, fear of pain, and the need for sedation. The technology behind standard optical colonoscopy basically consists of a long semirigid tube with a steerable head, which is relatively stiff compared with the compliant nature of the colon; as a result of this “back–wheel drive” approach, looping occurs during insertion leading to pain and potential tissue damage or even perforation. Colon capsule endoscopy and innovative robotic colonoscopes solve the drawbacks of pain and discomfort, but lack in reliability and diagnostic accuracy and fail due to an inability to combine therapeutic functionalities with the common screening purposes,. Furthermore, all these techniques are often extremely difficult to learn and master; moreover, the strict dependence on the operator skills induces subjectivity to the procedure and a consistent relevant cost for the healthcare system willing to deliver a standardized procedure (Figure 1).
EndoVESPA aims to develop an active colonoscopic platform for robotic guidance of a painless, innovative, smart, and soft–tethered device, in order to achieve accurate and reliable diagnosis and therapy of premalignant polyps and / or colonic pathologies. In this framework, the expertise and know–how of the EndoVESPA Coordinator and Partners in the field of robotic endoscopy are combined with an intraoperative environment reconstruction, and with sensing strategies, which aim to assess and classify the current robotic device actions, coupled with magnetic control, and thus produce a robust and effective platform for painless colonoscopy.
The EndoVESPA colonoscopic methodology arises as almost a natural progression of current colonoscopy platforms, towards clinical improvements; it is also a direct evolution towards industrial assessment of the endoscopic platform and smart robotic devices developed by the EndoVESPA Coordinator,. The 20–year tradition in robotics and miniaturized devices for diagnostic and therapeutic applications of the proposal Coordinator team will be exploited to develop, at the end of this 3–year project, a reliable product for widely accepted, painless colonoscopy. The complete EndoVESPA system is featured as a novel and high impact colonoscopy platform with the potential to become a real signature Project. Closed–loop magnetic navigation, enhanced diagnosis and therapy have the potential to eradicate most of the limitations and drawbacks of current colonoscopy in terms of discomfort for the patient, dependence on medical doctor advanced skills, and cost for the healthcare system. The ascertained acceptance of robotics in the medical theatre, as well as the mature implementation of computer–integrated technologies, represents the natural ingredients for the industrial–oriented development of the EndoVESPA platform at this time. In this framework, robotics and computer science methodologies can provide dramatic benefits to the colonoscopy medical scenario, making EndoVESPA a mainstream solution for current needs in colonoscopy. EndoVESPA will allow a truly life–saving procedure for all (Figure 2), with the advantages of:
- a painless procedure and a high acceptance by patients for preventive mass screening;
- ease of performing (due to robotic teleoperated guidance, diagnosis and therapy and embedded control capabilities, – reduction of required skills and thus standardization of procedure); and
- a tremendous social benefit and reduced costs for the public healthcare systems.
Thanks to the presence in the EndoVESPA Consortium of top–level academic, industrial and clinical Partners in the field of robotics and computer science systems, and thanks to the expertise and background in robotic endoscopy of the Coordinator and Partners, the Project objectives are fully achievable within 3 years with a real focus on developing an industrial product. The merging of navigation, high-effective diagnosis and targeted therapeutic strategies, enhanced emergence algorithms and human machine interface will lead to the development of a disruptive system for painless robotic colonoscopy.
EndoVESPA originates in the EU to meet the requirements of the call of Horizon 2020, after previous EU Project (i.e., the VECTOR and SUPCAM Projects, success stories in the 6th and 7th FP EU community). The concrete objective is translating acquired experience and developed advanced prototypes into a usable and deployable technology, thus reaching a TRL for accessing the endoscopic market within the Horizon 2020 timeframe with a disruptive robotic solution. EndoVESPA aims to push the technology developed within previous EU Projects already validated in a pre–clinical environment (between TRL 5 and TRL 6), towards a complete, qualified and advanced system for colonoscopic painless inspection (between TRL 7 and TRL 8). The expected final objectives of this process, defined to reach TRL 7/8 starting from TRL 5/6, are the following:
- an validation, optimization and advanced design of the current system in terms of technology robustness and reliability, both hardware and software;
- an optimization of the current system in terms of engineering and production costs;
- the set–up of the industrialization process, as a mandatory step for translating a prototype in a medical device towards the final approval of the European Community and then by the FDA;
- the creation of a large community of endoscopists (end-users) familiar with and enthusiastic about active capsule technology, at least at a pre–clinical stage;
- the delivery of a detailed business plan and its distribution to large industrial players (partially already identified) and to venture capital and stakeholders; and
- establish, with the involved SMEs, a real industrial process for the production and sell of a painless innovative colonoscope, as an alternative to the standard colonoscope and several versions of endoscopic derivative capsule solutions.
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