20 results
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…
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…
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…
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 -…
The primary objective of the proposed research is to investigate in patients with PDD the efficacy of STN-DBS with best oral medical treatment (DBS-group) for disabling motor symptoms during off-drug phase compared to best oral medical treatment…
To assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix compared to standard treatment (no cerclage) in the prevention of extreme preterm birth (PTB) < 28 weeks of GA.
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).
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…
To evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers. We hypothesize that RRS with delayed RRO leads to an equal ovarian cancer incidence when compared to RRSO.
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…
To compare postamputation pain (phantom limb pain and residual limb pain) one year postoperatively in patients receiving a lower extremity amputation with standard neurectomy versus those who received targeted muscle reinnervation.
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: 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-…
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 goal of this study is to investigate which treatment(-s) lead to the best outcome by using existing variation of practice.
The primary objective of this study is to evaluate the efficacy of the AtMoves Knee System in the clinical diagnostic process of aseptic knee loosening in knee prostheses. This will be measured by the number of *failed outcomes* resulting from…
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&…
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…