Project: Integrated Planning and Navigation System for Visceral Surgery
Primary Liver cancer and secondary metastasis in the liver are among the leading causes of death. The incidence of primary and secondary liver cancer is 1.2 Million new cases per year worldwide and the prognosis for patients affected is an average survival of less than a year if the cancer is untreated. The only treatment which can lead to complete remission is surgical removal of all the cancer lesions within the organ. Other treatment options, such as chemotherapy or radiation therapy can prolong live but have no potential for complete cure. Although surgical tumor removal is a highly effective treatment, only a 10-20% of the patients are eligible for surgery. For the reCOing 80-90% removing of the tumor lesions with a sufficient safety margin while preserving enough healthy liver tissue is not possible so far. Other treatment options such as Chemotherapy and Radiotherapy are palliative, hence, they can only reduce the rate of progression of the disease but can NOT lead to its complete cure._x000D__x000D_ Well established methods for computer-assisted planning of surgeries suggest, that surgical treatment of a larger fraction of liver cancer patients (of those 80-90% initially not eligibe for surgery) would be possible if surgical precision was increased. This project therefore aims to improve precision and safety in liver surgery through a instrument guidance system (IGS) dedicated for open liver surgery. Instrument guidance (also referred to as surgical navigation or computer aided surgery) technology provides intra-operative visualisation of 3D medical image data together with a correct spatial representation of a surgical instrument, just like the position of a car is displayed on an electronic road map in an automobile GPS navigation system. The principle can be extended to track and reference real-time (i.e. ultrasound, fluoroscopy) imaging together within preoperative imaging modalities. _x000D__x000D_ The transfer of such technology into a dedicated medical device has to deal with a number of complex integration tasks. Typically, the available medical image data (from the preoperative planning phase) and additional 3D models and/or planning data, cannot be used directly during the surgical process itself due to the deformation of the organ of interest (manipulation, patient position, breathing). Another challenge for the successful introduction of computer and stereotactic assistance into the OR is the availability of sufficient navigation hardware and the corresponding instrument extensions. All these components will have to be designed towards a focus on soft tissue interventions. Typical challenges are ergonomics, reproducibility, stability and precision and a medical device approval. Throughout the course of the iVisc project such a instrument guidance system for open liver surgery will be finalized, integrated and clinically evaluated. For an effective support each step in the clinical workflow – from preoperative surgical planning via the intra-operative guidance until the postoperative control – should be addressed in an integrated manner to optimize the support provided to the clinical user. Specifically, the following milestones will be achieved: _x000D__x000D_• Design and realization of a dedicated instrument guidance system for open liver surgery;_x000D_• Support computer based planning, intraoperative guidance, and postoperative control; _x000D_• Production of a prototype series of the dedicated navigation systems; _x000D_• Processing of the necessary steps for successful regulatory CE approval; _x000D_• Conduct necessary clinical trials to demonstrate clinical evidence and clinical feasibility. _x000D__x000D_ The proposed project consortium consists of the following Ps_x000D__x000D_• SME’s: CAScination GmbH/AG (CH) and MeVis Medical Solutions AG (GER);_x000D_• Academic research institutions: Fraunhofer MeVis (GER) and University of Bern (CH);_x000D_• Clinical sites: University Hospital Bern (CH) and Asklepios Clinic Hamburg (GER)._x000D__x000D_ The consortium Ps have collaborated more than 4 years on national and international funding schemes (DFG, BMBF, EU). Specifically, the project will benefit from the results of an ongoing national research project called SOMIT-FUSION, funded by the German Federal Ministry of Education and Research (BMBF), aimed at individualized precision surgery for soft tissue with a focus on liver surgery and interventions. The swiss consortium Ps are active since one decade in the SNSF funded National Competence Center for Research in 'Computer aided and image guided medical interventions' (CO-ME) and have been focusing on fundamental research aspects of this technology._x000D__x000D_ Furthermore, the consortium consists of Ps already providing image processing services to the worldwide community of liver surgeons conducting high risk liver surgeries for tumour removal and Living donor liver transplantations (LDLT). The project will hence benefit from strong foundations of its Ps.
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Acronym
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iVisc
(Reference Number: 6201)
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Duration
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01/04/2011 - 31/03/2014
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Project Topic
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Within the iVisc project a commercially available surgical instrument guidance platform dedicated for planable, precise and reproducible liver surgery will be developed and clinically evaluated. _x000D_ The iVisc consortium consists of 2 SME’s, 2 academic and 2 clinical Ps.
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Network
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Eurostars
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Call
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Eurostars Cut-Off 5
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Project partner
