27 results
To identify whether a short axis approach (SAA) or a long axis approach (LAA) to ultrasound guided peripheral cannulation is superior when performed by ED nurses without prior ultrasound experience.
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…
The primary objective of this clinical Research is: • The objective of the study is to investigate concept and feasibility of view automation for SHD interventions. The study will explore the contribution of (semi) automatic views based procedural…
The primary objective is to examine relationships between neurocognitive performance and MRI parameters of brain vasculature, metabolism, and white matter diffusion in children who have been treated for posterior fossa tumor. Secondary objectives…
Primary objective: - To develop an automatic segmentation algorithm using artificial intelligence for real-time intra-operative vessel segmentationSecondary objectives: - Post-operative evaluating the accuracy of…
The purpose of this study is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft System versus Gore Excluder/Excluder Conformable AAA Endoprosthesis in subjects with AAA.
Evaluation of the effect of different treatment thresholds in a clinical pathway for children with acute asthma who are treated with supplemental oxygen
We will combine four 7 Tesla MRI markers in extremely preterm infants (MRSI; SWI; PC-MRI; ihMT) to assess (1) if they can predict outcome until 2 years of age; (2) if they are of added value to 3 Tesla prematurity (Kidokoro et al., 2013) and (3) if…
To test the feasibility of image-guided navigation during robot-assisted prostatectomy
The primary objective is to demonstrate efficacy of an extended remote monitoring intervention, including a TM app, HF nurse guided home care and multidisciplinary network collaboration using the Virtual Ward platform, on top of standard HF care…
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 traditional feasibility study intends to inform a future pivotal trial in the following two ways. Firstly, it aims to evaluate the potential of neural health metrics triggered by FMS, to predict the implant recipient*s auditory performance -…
Primary objective (after 1 year)- To evaluate the effectiveness of the nurse-led GILL eHealth intervention in patients with serious mental illnessSecundary objectives (after 1 year)- Improve metabolic syndrome severity- Improve fitness, physical…
The primary objective of this study is to investigate if the use of Heli-FX EndoAnchors in conjunction with placement of aortic stent grafts under instructions foruse (IFU) conditions in aneurysms with a wide neck is superior to treatment with…
Part A: Determine the performance of using 4D DCE-BCT for tumour staging. Part B: Determine the performance of 4D DCE-BCT in monitoring of treatment response and prediction of final treatment outcome based on early response in patients that undergo…
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.
The primary objective of the PROTECT IV Trial is to demonstrate the superiority of percutaneous coronary intervention (PCI) performed with Impella® mechanical circulatory support (MCS; Impella CP®, Impella CP® with SmartAssist® or Impella 2.5®…
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…
This study has been transitioned to CTIS with ID 2024-515883-30-00 check the CTIS register for the current data. The primary objective of this study is to prove noninferiority regarding safety and effectiveness of 30-45 day of DAPT followed by…
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…