EndoVESPA is a highly interdisciplinary project, in which medicine, advanced robotics and, computer sciences will embrace and work together to achieve the final aims: a robotic platform for painless colonoscopy. Figure shows the work plan in terms of technical work–packages, describing how the scientific / technical domains are integrated in the project, and justifying the role of each partner of the EndoVESPA Consortium.
The EndoVESPA work plan is organized in six work packages (WP), including WP1 (devoted to administrative management and project coordination) and WP6 (devoted to dissemination, the exploitation plan and intellectual properties assessment), both represented in the diagram above. The technical work packages are four (WP2 to WP5), and their organization has been devised to take advantage of the Coordinator’s experience of coordinating large integrated and small or medium–scale focused research projects, most of them European.
A first technical WP (WP2) is devoted to refining and developing specific modules of the magnetically driven colonoscopy platform and to transfer the different developments into a clinical platform able to approach the European certification test and labelling process. It is worth mentioning that research is a small part of this project; mostly, the modules will be refined and engineerized. Specifically, WP2 is also devoted to defining and adapting a magnetically driven endoscopic platform and a soft–tethered colonoscope (developed by the proposal Coordinator in previous research activities and European projects, i.e. the FP6 IP European VECTOR project) for the EndoVESPA medical and technological purposes. In particular, a properly designed platform, based on the defined requirements and system specifications, will be developed taking into consideration regulatory issues for future certification and then commercialization. The different tasks of the WP2 will be based on both medical and technological requirements (updated in the first 2 months of WP2) together with certification and regulatory aspects defined in Task 5.1 for industrial labelling pathway definition towards CE marking. All those indications will mainly target the project leading application (e.g., the development of a colonoscopic platform), but they will also allow the applicability of project results to other applications, such as a controlled magnetic navigation of robots in unstructured and deformable environments.
WP3 is specifically devoted to the implementation of a 3D lumen mapping based on a multi–camera module, an optical image enhancement system and a smart sensing tool for tissue stiffness evaluation. All the activities of this work package are aimed at enhancing diagnosis (i.e., accuracy and reliability) and will be connected to the WP2 for a final system integration, approached in Task 2.6 - Endoscopic platform and soft-tethered capsule: adaptation and integration. It is worth mentioning that the developments of image-based hardware and software have been delocalized in a different work package, WP3, due to the importance of those aspects: images and optical image enhancement technologies will represent the main feedback to the user (i.e., the physician) for locomotion and diagnosis issues. The work package will consist of the integration of a multi-camera technology (for 3D stereoscopic vision) and optical and force-based enhancement systems onto the colonoscopic capsule for accurate and reliable diagnosis - the main aspect of a disruptive clinical solution in colonoscopy.
The technical work packages (WP2 and WP3) will be accompanied by an extensive experimental validation of the system and subcomponents (WP4), which will last for approximately the first two years of the project (until month 27 for providing along the technical development an experimental assessment in real conditions for adjustment and redesign) and will be even more strengthened thanks to the involvement of technical and medical Partners. The experimental phase, in in-vitro and ex-vivo conditions, will be performed on simulators, specifically selected and / or designed (e.g., sensorization of the test benches) in this work package and based on technical and medical experimental protocols. Together with the experimental validation of the single modules and platform, an important analysis will be also performed for comparing the EndoVESPA platform with the standard colonoscopy, accomplished with a traditional colonoscope; this task will be extremely important to technically point out the benefits of the EndoVESPA platform with respect to standard procedures. Finally, a risk analysis will be performed within this work package.
The industrial-oriented process will be approached in WP5. In particular, in parallel with the experimental validation of the EndoVESPA components and platform, a pre-compliance testing phase for CE marking will be performed for approaching in the last part of the project the CE mark Technical File compilation with lower risk of critical events during the certification process. In fact, an important milestone of the EndoVESPA Project is the preparation and submission of the CE mark Technical File for obtaining, after the end of the project, the CE process of the colonoscopic platform. Finally, a clinical protocol and documents will be prepared for ethical committee approval for experiments in humans; those documents will be compiled within the project but submitted to the ethical committee once the CE mark for the colonoscopic platform has been obtained.
Based on the outlined strategy, the EndoVESPA workplan has been organized in:
- WP 1: Project management and coordination
- WP 2: Magnetic navigation platform and robotic capsule
- WP 3: Optical 3D mapping of the lumen and diagnostic imaging
- WP 4: Experimental protocols and test
- WP 5: Industrial-oriented process
- WP 6: Dissemination and exploitation