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 study aims to determine the safety and efficacy of the steering module in a clinical setting.
To determine the effect of RIPC of the upper limb on the inflammatory response during human endotoxemia (infusion of LPS), as well as the additional effect of 7-day RIPC compared with single-dose RIPC.
The primary objectives are to demonstrate the safety and performance of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream…