Members of the Kriba team carry out the efficacy phase training of our clinical trial at Sant Joan de Déu Hospital. After closing the proof-of-concept phase with results of 94.4% sensitivity and 94.8% specificity, we conducted the first training of the efficacy phase with clinicians of the neonatology department of Sant Joan de Déu Hospital, an essential step before launching the III phase of our international multicenter clinical trial in Spain. This phase will evaluate whether the device works as intended in clinical practice, and it is a critical requirement for obtaining approval from health regulatory agencies.
Our device Neosonics, fully automated and non-invasive, also incorporates features that improve the user experience and measurements. Our objetive in this phase is to conduct a successful measurement in 1 to 2 minutes.
Training prior to this phase is training important because it ensures that all researchers and staff involved follow the same procedures and protocols, which is imperative for the integrity of the study, and to obtain consistent data. It also provides staff with the knowledge necessary to operate the device safely, and enables the successful acquisition and management of data, which is key to the accurate assessment of the device’s efficacy.
We are thrilled that during this session, a paediatrician from the CHU Ibn Sina – Hôpital des Enfants de Rabat, where the efficacy phase is ongoing, attended. A representative of the industry, member of Palex Medical, a medical distribution company was also present, and we are grateful for the interest shown in our work. We would like to thank the Neonatology department of SJD for welcoming us and we are looking forward to the successful launch of phase III. Hospital Sant Joan de Déu is a world renowned paediatric hospital and it is a privilege to be able to do research alongside its clinicians.
