4 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…
See protocol page 12The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing system and to assess long-term device performance.
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…
Objectives:To evaluate the following in NSCLC patients with EGFR or HER2 exon 20 insertion mutations (includingduplication mutations) who are treated with poziotinib:Primary Objective:Objective Response Rate (ORR)Secondary Objectives:• Disease…