The University Hospital of Besançon counts with sophisticated technical platforms, 1304 beds, 4300 support staff, and 827 medical staff. This clinical partner will be involved in µRALP through its Clinical Investigation Centre on Innovative Technology (Inserm CIT 808), ENT Department, Radiology Department, Institute of Anatomy and its Platform of Histopathology.

 

 

Organizations:

• Department of Otorhinolaryngology
• Clinical Investigation Centre – Technological Innovations

Main tasks:

• Leader of WP3 – Medical Imaging & Pre-Op Planning
• Leader of WP12 –Demonstration

Role of the Partner:

The CIT 808 will be responsible for preparing the specifications for a multimedia database, designing experimental studies, writing the documents necessary to carry it out, coordinate UHB interventions and organize interface with others partners of the project. It will also be responsible for the regulatory procedures (CNIL authorization, Ethical Committee, advice of Committee for the Protection of Persons - CPP) in relation to the study in cooperation with the Delegation for Clinical Research and Innovation (DRCI) of Besançon University Hospital.

All UHB departments concerned with µRALP will give their clinicians' expertise, collect needed data (clinical information, medical imaging and interpretation), participate to establish specifications and ergonomics aspects for new products, perform experimental studies (initially in virtuo for the learning curve, then on human cadaver) and contribute to publication and dissemination.

• The department of ENT surgery's role will be to define the specifications, particularly to respond to the medical and practical aspects, to carry out the surgical procedures in the pre-clinical studies, and to constitute the iconographic data collection of pathological cases. 
• The Clinical Investigation Centre for Technological Innovation (CIC-IT): its role will involve in management of ex vivo study on biological sample and of pre clinical trial and being involved in the specifications and the risk analysis for the new medical device. 
• The histology laboratory will carry out the necessary histological tests during the pre-clinical phase.

The Clinical Investigation Centre is approved by Inserm and the DHOS for two activities: biotherapies (CIC-BT approved in 2005 and renewed in 2010) and Technological Innovation (CIC-IT approved in 2008). The CIC-IT is already involved in medical device development through ANR programmes (MEDICALIP, Microelasto, STILµForce, S-Alive etc.), translational research (Smarttransfuser, Reve, Predios, Lactoxeros), and OSEO programmes (Miotheris, Ipsorte, Screen-air, K-skin). The Inserm CIT 808 is particularly active in the preparatory phases of the pre-clinical and clinical studies (regulatory procedures for study approval requests; writing study documents etc.) to realize these phases and to perform the adequate statistical analysis and reports.

Key researchers:

Lionel PAZART is an M.D. and has completed a Ph.D from Lille 2 University and postdoctoral studies from Brussels University School of Medicine (MPH). He is the director of Inserm CIT808 at Besançon University Hospital, a clinical research center dedicated to develop innovative technologies. He has published more than 25 papers in reputed journals, more than 100 communications and holds 6 patents.

Bruno WACOGNE received his PhD degree in optoelectronics in 1993. In 1996, he joined the Department of Optics of the FEMTO-ST Institute, as a CNRS researcher. He started to work on the use of microoptics and microtechniques for biomedical applications. His main topics now concern opto-microsystems and systems for In Vitro Fertilisation, biomedical devices, screening and diagnosis. Recently, he has been appointed by the University Hospital of Besançon. His additional work concerns the medical translational research.

Laurent TAVERNIER received his degree in Medicine and Surgery from the University of Franche-Comte University (France). He specialized in Otorhinolaryngology and Phonology at the ENT Department, University of Franche-Comte, and specialized in Audiologist. He is currently "First Level Medical Manager" at the ENT Department of the University Hospital of Besancon since 2004, and since November 2010 he is a Professor in Otorhinolaryngology at the University of Franche-Comte. Laurent Tavernier has conducted research in many ENT areas.

Jean-Michel BADET graduated in Medicine and Surgery in 1982 at Franche-Comte University (France). He specialized in head & neck cancerology from Institut Gustave Roussy (Paris, France) and in head & neck surgery in june 1997. He is currently enlisted as a medical doctor at the University Hospital of Besançon, and responsible for the cancerologic head & neck department. He is a member of different ENT scientific associations (Société française d'ORL, Collège français d'ORL, Société française de carcinologie cervico-faciale) and an active member of the GETTEC (Head & Neck Cancer Task Force).