9 results
To understand the mechanism of action of OA for the treatment of de novo, severely calcified coronary lesions prior to stent placement using optical coherence tomography (OCT) and to assess stent expansion, based on OCT derived minimal stent area (…
This study has several objectives, in different (subsequent) study phases:• A1. Optimize and validate the technology of the VD to reach non-inferiority• B1. Demonstrate non-inferior performance and safety of the VD, for CE marking• B2. Demonstrate…
The purpose of this prospective, pivotal, multi-center, single-arm cohort, pre-market, investigational clinical study is to assess the safety and performance of Deternia* Self-Gripping Resorbable Mesh when used for suture line reinforcement after…
The primary objective is to explore whether central sensitization and/or abnormal CPM responses are present in (a subgroup of) patients who will receive shoulder arthroplasty for osteoarthritis, and whether shoulder arthroplasty produces change in…
This study aims to assess the safety and efficacy of the remed*® system in adult patients with moderate to severe central sleep apnea in real life.
Objective: This protocol describes a framework that will be used to create different studies. The general primary and secondary objectives of this protocol are stated below:Primary objective: Investigate the effect of surgery on the position and…
To evaluate the safety, feasibility and efficacy of an 8-week remotely supervised home-based maintenance exercise training program following pulmonary rehabilitation in patients with COPD.
The aim of this study is to investigate the safety and efficacy of CAL-WR as primary and curative colon-preserving treatment for T1 colon cancer. Our primary endpoint is reduction of oncologic resections for low-risk T1 colon cancer. As secondary…
Evaluate the safety and efficacy of Medtronic Intrepid* TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation who, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of…