25 results
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:- To compare adenoma detection rate (ADR) with versus without real-time automated detection (CAD EYE, Fujifilm)Secondary Objectives:- To compare the size, morphology and histology of adenomas detected and resected in both arms of…
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).
To compare the clinical and angiographic outcomes of a strategy of native vessel PCI with SVG PCI in patients with prior CABG presenting with SVG failure and a clinical indication for repeat revascularization, as determined by the local Heart Team.
The aim of this study is to determine whether multiparametric MRI (mpMRI) of the bladder, in combination with an outpatient biopsy for histological confirmation, is a faster, safer, cheaper and therefore more cost-effective way to detect or…
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 main objective is to study the effect of the nutritional intervention versus the control product on white matter development (as assessed using tract based spatial statistics of fractional anisotropy) using a DTI scan at the corrected age of…
To determine whether CDT in high-risk PE relative to systemic thrombolysis is:- more effective and safer in terms of a reduction of the composite endpoint on all-cause mortality and adverse events defined as treatment failure, major&…
The main aim of the current study will be to determine the metabolic fate of dietary protein. More specifically, the main aim is to assess the incorporation of protein-derived amino acids in a wide variety of organ tissues in vivo in humans.
Primary objective: 1. To validate the data quality and diagnostic accuracy of StrokePointer to detect LVO stroke among patients with a suspected stroke in the pre-hospital setting. Secondary objectives:1. To determine the user-…
The purpose of the pivotal study is to determine the safety and efficacy of IMPEDE-FX RapidFill for increasing the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label EVAR stent graft…
The primary objective of the study is to determine whether AVIM therapy in combination with medical therapy is more effective at reducing ambulatory systolic blood pressure (aSBP) and to determine whether AVIM therapy is safe.
Primary Objective: Primary Objective: 1. To investigate the effect of a VR modality as an education tool for patients undergoing oncological lung resection, compared to standard-of-care patient education in managing preoperative anxiety. 2. To…
A Prospective Multicenter Trial to Evaluate the Safety and Effectiveness of the ELANA Heart Bypass System in Patients undergoing Coronary Artery Bypass Grafting (SAFE-CAB)
This proof-of-principle evaluation aims to investigate whether a home-based balance training using an exergame (HEROES), following a single session of perturbation-based training improves reactive step quality in people with chronic stroke.
The Check@Home consortium aims to set up a roadmap and infrastructure for a (cost-)effective program to early detect atrial fibrillation and chronic kidney disease (defined by elevated albuminuria) in the general population. Furthermore, the…
Primary Objective:Our overall aim is to develop an easy-to-use, and interpretive method for the early detection of valvular heart disease and thoracic aortic aneurysm based on arterial blood pressure waveforms, collected non-…
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…
The aim of this research is to decrease the number of involved margins, resulting in less adjuvant therapy and less local recurrences.
To assess the efficacy of treatment with Endocalyx for chronic heart failure.