5 results
The purpose of this Clinical Investigation Plan is to collect data on the safety and performance of the WiCS-LV system. It is designed to satisfy requirements for clinical data and post market clinical follow-up for the Active Implantable Medical…
5.1 Primary study objectives:5.1.1 SafetySafety of the device has been defined as 1. Device-related complications (24 hour perioperative and one month) 2. Procedure-related complications (24 hour perioperative and one month) 5.1.2…
To gain insight into the full spectrum of temperature-induced changes in glucose homeostasis, the present study will be aimed at assessing the effect of acute whole-body heat exposure on liver insulin sensitivity, substrate oxidation and plasma…
The primary objective of the UNLOAD-CHIP is to investigate the combined clinical endpoint (as described in primary and secundary endpoints).
The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of gMG in adults with autoantibodies against AChR (AChR+). The study will also evaluate the safety and performance of the administration device (the PFS-…