3 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…
The primary objective of this study is to evaluate the long-term safety and tolerability of Diacerein 1% Ointment for 2 treatment cycles in subjects with EBS that were previously enrolled in studies CCP-020-301 or CCP-020-101.