44 results
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…
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.
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…
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…
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)…
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 (…
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…
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…
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 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 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 aims to assess the safety and efficacy of the remed*® system in adult patients with moderate to severe central sleep apnea in real life.
To test the feasibility of image-guided navigation during robot-assisted prostatectomy
Clinical feasibility of the urine collection device, indicated by staff and parents.
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.
To evaluate the effect of transcutaneous electrical nerve stimulation (TENS) in patients with ANOCA on the change in the summary score of the Seattle Angina Questionnaire (SS SAQ) after 1 month treatment with TENS, compared to baseline.
The objective of the study is to evaluate the benefit of the eCoach in the general practitioner*s office within cardiovascular risk management. Specifically, the eCoach evaluates the effect on individual risk factors and the risk on developing…
The objectives are to determine the accuracy and reliability of sCT compared to conventional CT regarding (1) classification ofshoulder osteoarthritis morphology and (2) planning for the 3D-position of a compound used for shoulderreplacement…
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 (…