WP4 (UNICAMPANIA) [months 3-21] – Patients recruitment and data collection

This WP deals with the clinical trials of the proposed new system. Once the sensors are available (see WP3), it will be possible to start the measurement campaign involving the groups of patients specified by WP2. Initially, data acquisition will be carried out in the clinical setting at the follow-up visits that patients undergo after fistula surgery.

After physical examination of the patient and any investigations with medical devices such as Doppler ultrasounds, the patient will be trained by physician to properly use the sensor, record data, use the telemedicine app. In this way, the data recorded by the sensor can be precisely related to the outcome of the examination and the quantitative diagnostic information generated by medical devices. During data acquisition in the clinical setting, the ease of use by patients will also be quantified. After testing in the clinical setting, a subset of patients will be selected to perform signal recording from their homes on a weekly basis. Self-monitoring and DUS performed at one week, one month, 3 months and 6 months after surgery will be compared. A correlation curve will be drawn and calculated to relate the recorded signal with DUS parameters (vessel flux and diameters). Measurements will be recorded at the AVF anastomosis and on several points of the forearm, along the course of the arterialized cephalic vein. The entire measurement campaign will take place over a period of 12 months. All these data will form the database that will be useful both for the trials planned in this project but also expected to be made available to the scientific community for further analysis. The patient database resulting from data collection is the deliverable D3 of the project.