55 results
This study is designed to gather prospective data on a) the clinical effectiveness, b) the tissue structure changes, and c) the short term costs of ankle joint distraction (AJD) in 10 patients with HAA during 10 years follow-up.
Establishing efficacy and safety of the electrodes and implantable pulse generators (IPGs), which are used for deep brain stimulation (DBS) in patients with obsessive-compulsive disorder (OCD).
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…
To test the feasibility of image-guided navigation during robot-assisted prostatectomy
The purpose of the VISABL-VT clinical investigation is to demonstrate safety and efficacy of RF ablation of ventricular tachycardia (VT) attributable to ischemic cardiomyopathy (ICM) with the Vision-MR Ablation Catheter 2.0. Data collected from…
To demonstrate the ability of using non-invasive 31P-MRS to monitor changes of in vivo markers of mitochondrial function in skeletal and cardiac muscles (i.e., skeletal muscle PCr recovery rate constant and cardiac PCr/ATP ratio)…
The aim of this research is to decrease the number of involved margins, resulting in less adjuvant therapy and less local recurrences.
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 (…
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 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 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…
We want to show in the current pilot trial that the current market ready automated device is safe and effective to use in humans as the proof of principle prototype, as well as check the instructions for use (IFU).
Primary objective of this clinical investigation is to evaluate superiority of the signal quality of SOFT ECoG flexible high-density electrode grids compared to regular high-density electrode grids, routinely used at the UMC Utrecht. The signal…
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…
The purpose of the investigation is to confirm the safety and efficacy of the InDx implant in treatment of CMC osteoarthritis.
The objective of this study is to determine the ability of respiratory EMG measurements with a wearable to …