4 results
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 the study is to collect safety and performance data of the IlluminOss Photodynamic Bone Stabilization System when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic…
Primary ObjectiveEstimate the proportion of subjects fulfilling criteria for symptomatic remission (as defined by Andreasen et al.)* following a transition to 12 months* treatment with flexible-dose PP3M in subjects with schizophrenia previously…
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…