Update on site start-up and regulatory processes
As a multicenter, prospective study, SHIELDS involves eight European sites, spread across Belgium, France, Germany, Italy and The Netherlands. Currently, four sites have been activated ready to enroll patients: three in Germany (Hamburg, Oldenburg, Berlin) and one in Italy (Verona).
In Germany, ten patients have already been recruited and treated. Further enrollment will continue after the National Competent Authority has positively evaluated the seven-day follow-up report from this cohort. This restart is anticipated shortly. At that time, our fourth German site in Göttingen will also be initiated. More on the results from this initial cohort can be found below.
Our Italian partner, Verona, received approval at the beginning of December 2020. The first two patients were successfully enrolled on December 21st and 22nd, 2020.
Our planned sites at Ghent, Amsterdam and Lyon are all currently under Ethics Committee (EC) / Competent Authority (CA) review and are expected to be allowed to start enrollment during the course of January and February 2021.
Based upon all sites’ recent communications for enrollment rates, the complete study population (N = 80; of which 40 liver and 40 pancreas patients) is expected to be finalized by the end of April 2021.