Chronius

News & Events

8th General Meeting

28th – 29th September, 2011 9:00 – 18:00 / 9:00 – 16:00
Meeting Venue: Potsdam, Germany

7th General Meeting

28th – 29th March, 2011 9:30 – 18:00 / 9:00 – 16:00
Meeting Venue: Spain, Universitat de Barcelona

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  • COPD
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Clinical Validation

The pilot site will be setup and the clinical validation phase will commence. A clinical validation protocol will be prepared and approved by the project Medical Board and submitted to the Hospital Ethical committees. The system will be extensively tested both from the technical point of view as well as from the user point of view and the final system will be produced. Finally, the system will be validated, in two phases (A and B), by the healthcare professionals according to pre-defined validation protocol.

• In the Phase A, 50 real subjects (30 in the Careggi Hospital in Firenze and 20 in the Feltre Hospital) will be recruited in order to test and validate the system's components and services. The main expetcted results are the determination of accuracy, reliability and usability of the platform and the creation of a Database of experimental tracings from healthy subjects and patients. Measurable indicators will be identified in order to understand and assess system performance. Patients and physicians involved in this study will be asked to fill a questionnaire prepared in order to provide clear results on the ease of use, the efficacy and the usability of the system.
• In the Phase B a series of extensive trials will take place to validate the system and its services on real patients, selected with appropriate inclusion and exclusion criteria,in home settings. During this phase the final version of the medical validation plan of the platform will be drawn. All appropriate material (consent forms, relevant information sheets etc) will be prepared and distributed to people involved in Clinical Validation Phase B.

The aim of the validation will be to test the hypothesis that the trained CHRONIOUS platform is able to automatically track patient health status in a way equivalent to the clinical assessment, so that CHRONIOUS could predict potential changes in patient disease.