Department for the clinical assessment of medical devices

Developing innovative technological research protocols for patient care.

The Clinical Assessment Department, or patient-subject sector, is a Grenoble University Hospital medical unit, attached to the research department. It is licensed by the Agence Régionale de Santé (Regional Health Authority). It focuses on translational research in the fields of micro- and nanotechnology and electronics. All clinical investigations are carried out as part of clinical trials which are validated by regulatory bodies such as ANSM, the French National Agency for Medicines and Health Products Safety and Grenoble University Hospital’s ethics committee.

The patient-subject sector was set up to make a clinical ward available for early-stage protocol development, working on proof-of-concept for the use of innovative technology in human healthcare. The sector is open to all clinical, academic and industrial research investigators and meets the new clinical validation requirements for medical devices in compliance with new European regulations.
A full medical and paramedical team ensures safety and the application of clinical research protocols.
Clinical treatment may entail day admission or hospitalization, meaning that a range of multimodal investigations can be carried out at a single site, thereby speeding up the safe development of innovative health technology.

The team of healthcare professionals is actively involved in applying the protocols and is included in discussions on the subjects under research.
Last, the healthcare professionals remain in close contact with Grenoble University Hospital to improve their skills in treatment techniques.

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Equipments

The patient-subject sector has six rooms for patients, a room for validating external electrophysiological monitoring technology (especially that used for monitoring brain activity) and an advanced multimodal operating suite.

Its cutting-edge equipment includes:

  • 1.5 Tesla intra-operative MRI (the only system of its kind in France)
  • SPECT-CT
  • Magnetoencephalography
  • Optical imaging (Fluoptics and Maunakea technology)
  • ROSA bio-surgery Robots (Medtech)
  • Electrophysiology
  • Motion analysis platform
  • Interventional cellular and molecular biology
  • It is involved in developing interventional optical technology.

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Patient support

The team’s primary objective is to provide optimal care for the patient.
Healthcare professionals and technologists work in synergy to provide quality care and an environment in which values, experience and knowledge are shared.
The amount of time devoted to supporting and listening to the patients, all of whom volunteer to take part in a research protocol, means that they receive personal treatment in a dedicated environment.
The healthcare team provide information to the patients from the moment they meet to discuss inclusion in trials. It is then involved in all follow-up appointments, implying personalized contact and regular, individual follow-up.
The relationships between the team and the patients are founded on humanist values and ethics shared by everyone at Clinatec, working in partnership in an environment of mutual trust.