Title: A family of Smart Endoscopic Instruments for the Gastro-Intestinal Tract
Funder: Health and Care Research Wales (Welsh Government)

Abstract: The proposed project comprises seven broad work packages, each with a number of more detailed activities. Work Package 1 comprises enhancements to the Platform Radio Frequency & Microwave Energy Source/Generator to optimise its performance in powering the new family of three additional instruments, and add the capability to generate Thermal Plasma for the Argon Beam Coagulation function. This work package will include software design and validation, and some enhancements to the existing hardware design. By the time the proposed project starts, the Platform Generator will already be CE Marked, so this work package will include additional validation testing and electrical safety testing to ensure that the augmented device can retain a CE marking. Work Package 2 will comprise the development of a new endoscopic instrument - a microwave coagulating snare. This instrument will combine a traditional cold snare with a small, highly-optimised microwave antenna, capable of radiating microwave energy precisely into the stalk of a polyp, and not into surrounding tissue. The work package will include bench testing and assessment, the whole range of medical device development activities to ensure safety, biocompatibility and high levels of performance, as well as external validations such as sterilisation validation. A batch of 200 instruments will be constructed for lab-based evaluation and validation work, culminating in the completion of the 'technical file' for CE Marking. Work Package 3 will comprise the development of a novel combined surface and deep coagulation instrument. The surface effect will be generated with a new form of Argon Beam coagulation - using Radio Frequency energy to initiate the plasma, and Microwave energy to sustain it. This approach has been proven to work for other Creo projects, and offers much greater control and safety - as unlike existing Argon Beam devices the patient is not part of a high voltage electric circuit. The deep coagulation effect will be delivered by non-ionising radiation in the microwave band - very carefully designed for a well-controlled depth of penetration into the tissue. This work package will also include the necessary design proving and external validation work in support of CE Marking, and 200 instruments will be produced as part of this process. Work Package 4 will comprise the development, validation and CE Marking of the third instrument - the Radio Frequency and Microwave grasper. The RF and Microwave principles employed for this work have been proven to work in the current project - the key challenge here will be in miniaturisation of a grasping mechanism for endoscopic use, whilst integrating the sophisticated RF and Microwave technology and achieving a viable manufacturing cost. Work Package 5 will comprise the clinical and regulatory work necessary to secure CE marking of the enhanced generator and family of three further instruments. This work will build on the regulatory experience currently being gained within the company as it CE marks its first product as part of the current i4i project. Work Package 6 will comprise Project Management and IP protection for the enhancements to the generator, and the three new instruments. Work Package 7 will be the Patient and Public involvement programme, as described at section six.

Lay abstract: Creo Medical Ltd is currently developing innovative technology to facilitate the early and safe treatment of pre-cancerous and early-stage cancerous growths in the bowel as low-risk out-patient procedures, avoiding expensive and risky surgery later on. This work is funded by a current i4i award, and is on track to complete in December 2013. This current project is targeted at a small niche type of growths in the bowel wall - the type that are flat on the bowel wall (known as sessile polyps) rather than the stalked lumps that project into the bowel. This proposed project aims to build on the technology that has already been developed for the current i4i project to enable a much broader range of instruments to be developed. This broader range will then be able to treat the vast majority of growths found in the gut, increasing the cost savings to the NHS and improving outcomes for patients. Central to this innovation is the use of technology from the communications sector (very controlable energy in the 'microwave' band of frequencies) to coagulate blood vessels much more effectively than current techniques. Careful control and prevention of bleeding is key to safe and swift procedures, unlocking the potential to treat much greater numbers of growths in an out patient clinic rather than with surgery.

Research activity codes: 5.3 MEDICAL DEVICES
Health categories: CANCER AND NEOPLASMS;ORAL AND GASTROINTESTINAL