ENCASE II study
This month, we have taken another step towards entering the US market with LIQOSEAL®; we are happy to inform you that we received confirmation from the FDA that we can start ENCASE II in the USA. We are currently finalizing preparations to start enrolment for ENCASE II in April 2021.
ENCASE II is a randomized, two-arm, multicenter study, evaluating the safety and efficacy of LIQOSEAL® in reducing CSF leakage following elective cranial surgery. The study will involve world-class clinical centers in Europe (8) and the US (10), with the option to extend this to include 20 sites in total worldwide. Figure 1 shows a map of these sites.
All of these centres expressed specific interest in participating in ENCASE II, recognizing the game-changing potential of LIQOSEAL® as a dedicated neurosurgical device. We are very happy to have these expert surgeons and their knowledgeable teams involved and we look forward to the start of the study.