36 results
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 is to demonstrate efficacy of an extended remote monitoring intervention, including a TM app, HF nurse guided home care and multidisciplinary network collaboration using the Virtual Ward platform, on top of standard HF care…
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 -…
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 assess the feasibility of a larger study comparing HFNO with NIV as first line treatment in hypercapnic, acidotic AECOPD.
The primary objective of the PROTECT IV Trial is to demonstrate the superiority of percutaneous coronary intervention (PCI) performed with Impella® mechanical circulatory support (MCS; Impella CP®, Impella CP® with SmartAssist® or Impella 2.5®…
The primary objective of this study is to test whether deepening post-treatment sleep each night of a 5-day treatment program for PTSD using EEG-guided acoustic stimulation, will result an augmented overall treatment effect. In addition, two…
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 aims to assess the safety and efficacy of the remed*® system in adult patients with moderate to severe central sleep apnea in real life.
This study has been transitioned to CTIS with ID 2024-515883-30-00 check the CTIS register for the current data. The primary objective of this study is to prove noninferiority regarding safety and effectiveness of 30-45 day of DAPT followed by…
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.
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 cost effectiviness of the SENS-U (continuous ultrasonic bladder monitoring) in urotherapy for children with functional daytime urinary incontinence.
An Open-label Extension Study of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis
To evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with IPF.
To investigate the effect of implementing continuous antepartum eCTG monitoring at the OHC, on perinatal and maternal outcomes and obstetric care
The primary objective and hypothesis is to assess whether the SP-GRIPFLOW Catheter is safe and performs as intended. The primary hypothesis is that blood flow through the catheters and cerebral perfusion during open surgical repair of the distal…
The main objective of this trial is to determine whether reusable catheters are not less efficient as single use catheters, measured by symptomatic UTIs. Secondary objectives are adverse events like hospital admissions due to UTIs, urethral damage/…
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 primary objective of this study in people with PD is to examine the clinical feasibility, in terms of safety, adherence, performance and user experience (i.e., patient and physiotherapist), and effectiveness of home-based gamified cueing-…
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…