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…
The major aim of this study is changes in tinnitus loudness (daily report mark) and annoyance (daily report mark) and the duration of this change (time).
The primary objective of this phase III study is to demonstrate that lixisenatide can reduce cardiovascularmorbidity and mortality (composite endpoint of cardiovascular (CV) death, non-fatal myocardialinfarction (MI), non-fatal stroke,…
Main study:Primary objective: What are the long-term effects (i.e. after 8-week drug exposure) of the GLP-1RA versus a single dose prandial insulin onrenal hemodynamics (glomerular filtration rate/ effective renal plasma flow in basal insulin-…