WP4: Experimental protocols and test

OBJECTIVES and TASKS

The medical assessment of the technologies implemented and developed will be an on–going effort and will involve not only the assessment of the entire EndoVESPA platform, but also the experimental validation of the interim steps developed on the pathway. This approach will ensure that technologies and methodologies are developed and implemented under a continuous supervision and evaluation phase and according to technological and medical requirements and preconditions. The objectives of this work package are to provide direct medical and experimental feedback to the Consortium Partners engaged with technology and methodology development and to provide an evaluation of the safety and functionalities of the EndoVESPA platform and subcomponents, towards specific tests for the certification process. Specific experimental simulators and protocols will be properly developed and / or adapted (Task 4.1 - Experimental simulators and protocols) in order to perform a technological and medical validation of the EndoVESPA single subcomponents (Task 4.2 - Medical and technological assessment of single subcomponents) and entire platform (Task 4.3 - Medical and technological assessment of the EndoVESPA platform). In particular, the aim of this work package is to define the material and methods for the medical and technological assessment of the EndoVESPA platform and related single subcomponents and to perform dedicated validation sessions in several operating conditions for evaluating the functionalities, effectiveness and dependability of the systems. It is worth mentioning that the technological and medical assessment will be performed considering industrial requirements (from Task 5.1 - Industrial labelling pathway definition for CE mark) for approaching the CE certification. Key know–how, technologies and spaces constitute essential elements for the validation process, making OVE, UNITO and UEDIN smoothly integrated within the EndoVESPA vision and suitable for the medical and technological assessment role. Moreover, a comparison study of the EndoVESPA system performances vs. standard colonoscopy will be performed by the medical Partners, together with evaluation sessions for acceptability and dependability assessment, training and education (UNITO and UEDIN – Task 4.4 - Comparison with standard colonoscopy, dependability and training). Finally, the work package aims to evaluate the risk associated with the EndoVESPA platform development along the entire project period (Task 4.5 – Risk assessment). To meet these objectives, the work package is divided into the following aims:

•    experimental simulators and protocols;
•    technological assessment of EndoVESPA subcomponents and platform;
•    medical assessment of EndoVESPA platform: comparison with standard colonoscopy;
•    risk assessment.

Task 4.1 – Experimental simulators and protocols (OVE, UNITO, UEDIN)
Task 4.2 Medical and technological assessment of single subcomponents (OVE, All Partners)
Task 4.3 – Medical and technological assessment of the EndoVESPA platform (OVE, All Partners)
Task 4.4 – Comparison with standard colonoscopy, dependability and training (UNITO, UEDIN, SSSA)
Task 4.5 – Risk assessment (SSSA, All Partners)

OVE will be the WP leader