19 results
We hypothesize that sleep apnea screening, using a combination of an online questionnaire and high resolution overnight oximetry, can safely be applied to exclude sleep apnea with high sensitivity (≥97%) and acceptable specificity (≥60%) in patients…
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…
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…
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…
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 identify if, how and when VR is of added value in current treatment methods for people with SAD and MBID.
Primary ObjectiveTo evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS).Secondary Objectives1. To evaluate the change of menstrual blood loss (MBL).2. To evaluate the effect of MBL on the quality of life (…
The aim of this study is to evaluate the safety and efficacy of the esophageal partially covered SEMS. We will pay specific attention to recurrent dysphagia rates, migration rates and pain.
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…
The objective of this study is to accumulate clinical data on the safety and performance of NBGM200 embolization in patients with degenerative OA of the knee refractory to conservative treatment so as to provide evidence of conformity with…
The primary objective of the study is to assess the feasibility and safety of sequential ETLA treatment in patients with severe emphysema with hyperinflation. The secondary objective of the study is to assess efficacy of sequential ETLA treatment…
The objective of this trial is to confirm that there are no new safety and performance outcomes for participants receiving the Axonics SNM System INS Model 4101 for the treatment of OAB and FI. The only notable difference between the existing,…
Primary objective:To evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System.Secondary objective(s):The secondary objectives are to evaluate…
The main objective of the study is to optimize the use and user-friendliness of the voice analysis program, which could potentially help with the early detection of acute deterioration in heart failure. Hopefully, we can develop a technique that…
The general aim of this project is to determine the (cost-)effectiveness of footwear modification in addition to GP-led usual care, compared to GP-led usual care alone for patients with first MTP joint osteoarthritis (OA) at 6 months of follow-up…
The ultimate objective is to optimize pessary treatment for all patients with pelvic organ prolapse (POP). To reach this goal, we need to learn more about the mechanisms behind success and failure of pessary treatment. Previous research suggested…
The primary objective of this study is to assess the safety and performance of the ABLE Daily to perform ambulatory functions in home and community settings for people with spinal cord injury.The secondary objectives are to assess the impact of the…
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-…