65 results
Primary Objective To describe how patients experience the first eight weeks after shoulder arthroplasty, regarding pain and pain medication, shoulder function and quality of life. To determine the direct effect of patients' expectations on…
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…
Our primary objectives are to determine the diagnostic accuracy of handheld RCM in the diagnosing and subtyping of BCC in the head and neck compared to punch biopsy, and evaluate the associated rate of over- and understaging of BCC subtypes. In…
The rationale of this study was to investigate the alteration of colonic motor patterns in the early postoperative stage and between patients with no or minor LARS-symptoms (LARS-score < 30) compared to patients experiencing major LARS…
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…
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 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 (…
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.
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…
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 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 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…
To test the feasibility of image-guided navigation during robot-assisted prostatectomy
In the present pilot study, we intend to test phenotypic flexibility (Phenflex) in 20 clinically stable patients with COPD by exploring their response to a dietary challenge test before and after pulmonary rehabilitation. Moreover, the…
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 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.
Clinical feasibility of the urine collection device, indicated by staff and parents.
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 objective of this clinical investigation is to evaluate the safety and performance of the BeGraft Aortic covered stent Graft System & the BeGraft Peripheral covered stent Graft System (Bentley Innomed, Hechingen, Germany) in CERAB…